Young people are experiencing rare cases of heart inflammation after getting coronavirus vaccines, but doctors say the risk of COVID-19 is far greater

pfizer vaccine us
Pfizer-BioNTech’s COVID-19 vaccine.

  • Young people who got COVID-19 vaccines have reported higher rates of heart inflammation.
  • The CDC is investigating whether there’s a link between the Pfizer and Moderna shots and these events.
  • Even if there is a link, doctors said, the risk from COVID-19 is far greater than from the vaccines.
  • See more stories on Insider’s business page.

Young people who received the Pfizer-BioNTech or Moderna coronavirus vaccines have reported higher-than-usual rates of heart inflammation and swelling, US health officials said on Thursday.

The findings are preliminary and come from a self-reported database of side effects. The Centers for Disease Control and Prevention hasn’t confirmed a link to the vaccines, though researchers are investigating these incidents of heart inflammation, known as myocarditis, and heart swelling, known as pericarditis.

The CDC said it planned to convene an advisory group to discuss the issue on June 18. Earlier this month, Israel’s health ministry said there was a “probable link” between Pfizer’s vaccine and heart-muscle inflammation in young men.

In interviews with Insider on Thursday, cardiologists and infectious-disease specialists said the risk from the vaccine is still tiny compared with the potential damage from getting infected with the coronavirus. Not all experts are convinced there’s a link between the events and the shots.

“It’s not a no-brainer that there’s an association, because the season for getting myocarditis is around now,” Dr. Lorry Rubin, the director of pediatric infectious diseases at Northwell Health’s Cohen Children’s Medical Center, told Insider.

A group of viruses called enteroviruses is the most common cause of myocarditis, Rubin said. Those viruses typically circulate in the summer.

“That’s not the sole cause, but that’s the most common infectious trigger for myocarditis, and that’s more of a seasonal infection,” he said.

All three experts agreed that getting vaccinated, even for young and healthy men and boys, is still the best option.

“You definitely should choose vaccination in that age group because it’s safer than wild-type virus infection,” said Dr. Leslie Cooper, a cardiologist who specializes in myocarditis at the Mayo Clinic.

Coronavirus vaccine Moderna trial college students transmission study
A student getting his first dose of the Moderna vaccine.

Early reporting shows more heart side effects than expected

The preliminary data suggests elevated rates of the heart issues among younger vaccinated people, ages 16 to 24. At a Food and Drug Administration advisory meeting on Thursday, CDC officials shared data that included about 12 million doses given to people in this age range. CDC officials said that they would typically expect to see 10 to 102 cases of these heart events in this group but that 275 confirmed cases had been reported.

Most of these cases came after the second dose and were commonly reported in men, according to the preliminary data. The CDC said it was still confirming and investigating these self-reported cases.

The most common symptoms were chest pain and elevated levels of cardiac enzymes. Most of these cases were short-lived; at least 81% of people had already fully recovered from their symptoms, according to the data.

Even if the cases are linked to the vaccine, experts said, the greater risk, by far, is COVID-19.

“We’re talking about an incidence of myocarditis from the vaccine that is 100 times lower than the incidence when you actually get the infection,” Dr. Eliot Peyster, a cardiologist at the University of Pennsylvania, told Insider. “So, yes, it’s probably twice as likely as people who don’t get the vaccine, in a vacuum. But we aren’t in a vacuum. We’re in a pandemic where young people who get the virus get myocarditis in about one in 300 cases.”

Peyster cited a study of college athletes that found that roughly one in 300 had myocarditis after recovering from COVID-19.

The incidence rate among younger people who got the COVID-19 vaccine is still being determined, CDC officials said on Thursday. The agency said it would have more data to present at another meeting next Friday.

Pfizer Vaccine Transport
A vial of Pfizer’s vaccine.

A strong immune response to the vaccine could be the culprit

The Pfizer and Moderna shots both use messenger RNA, a new technology that had not been used in a federally approved medicine before the pandemic. Despite its newness, experts said they didn’t think these cases stemmed from something unique to the technology.

Peyster said he would guess it was from a robust inflammatory response to the vaccine, particularly after the second dose.

“Any systemic inflammatory condition – any kind – can generate enough inflammatory stuff where you can actually get a little bit of heart-muscle damage just through systemic inflammation,” he said.

While more than 140 million Americans have been fully vaccinated, the concerns about younger people come as the vaccines start to be used in younger populations. Pfizer’s vaccine was OK’d last month for children as young as 12 years old. Moderna applied for a similar authorization on Thursday.

Not enough shots have been given and tracked in the 12-to-15-year-old population to know whether these heart side effects could be a concern for that age group. Both vaccine developers have said they’re testing their shots in even younger children and infants.

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A teen receiving Pfizer’s vaccine at a vaccination clinic in Melbourne, Florida.

Experts guess that heart side effects will be less common in younger children

Rubin said he didn’t think there was reason for concern among parents deciding whether to get their children vaccinated.

“We don’t know if there’s a causal relationship, and it appears that the rate is low given the millions of people in the 12-to-25-year-old age group who have gotten this vaccine,” he said.

Peyster said he expected that these heart side effects would decrease among the younger ages. Given the history of myocarditis, he said, it’s likely the incidence rate will peak with young adults and adolescents.

The medical experts were unequivocal that the vaccine is clearly the best option overall, for all age groups.

“The evidence says you are much more likely to have heart inflammation from the virus than from the vaccine, even in young, healthy people,” Peyster said. “Therefore, the clear recommendation is vaccine is better than no vaccine.”

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We visited a pop-up vaccine clinic in a New York neighborhood that was once a COVID-19 hotspot. Some residents say they’re having trouble taking off work to get the shot, while others still don’t trust the city’s commitment to the community.

sunnyside pop up vaccine clinic
Jackie Lopez, who leads the COVID Free Queens Coalition at Sunnyside Community Services

  • Here’s what it was like inside a one-day pop-up vaccine site at Sunnyside Community Services in NYC.
  • Walk-in vaccine recipients preferred the Pfizer vaccine over the Johnson & Johnson shot.
  • Workers are providing information on vaccines through town halls and text messages.
  • See more stories on Insider’s business page.

Leaders at Sunnyside Community Services, a non-profit center that serves neighborhoods in Queens, New York City, are well aware of the devastating toll COVID-19 has had on their community.

The coronavirus disease had killed more Queens residents than any other borough as of March 2020, when New York City became an epicenter of the pandemic. Queens has the second-highest death rate from COVID-19 among the five boroughs, according to the most recent city data.

In the area of Queens that encompasses Jackson Heights, Elmhurst, and Woodside, 1 in 12 people have had COVID-19 and 1 in 137 have died, according to The New York Times.

At a one-day pop-up vaccine clinic in New York City’s Sunnyside Community Services, workers said community members coming in to get a shot gave them hope about the COVID-19 pandemic’s end, but they will still work hard to ensure no vulnerable member gets left behind.

Jackie Lopez, who leads the COVID Free Queens Coalition at Sunnyside Community Services, told Insider though she feels hopeful about entering a new post-COVID era, she urged federal and state agencies to keep in mind how vulnerable communities have low vaccination rates.

Read more: From guaranteeing full-time work to giving out gas cards, the shorthanded home-care industry is pulling out all the stops to hire more caregivers

Lopez said she’s heard community members say they can’t get a vaccine because they can’t take days off work if they have side effects. Black and Latino adults have a lower rate of vaccination than the average, according to the University of Minnesota. A volunteer team with the Association of American Medical Colleges said low-income neighborhoods have less access to vaccines, and these residents struggle with navigating the online sign-up processes.

“Our Black and brown communities, our immigrant communities were hit the hardest by the pandemic and we still have work to do to provide accessibility and continue to provide information,” Lopez said.

Inside a pop-up vaccine clinic in one of the hardest hit areas of COVID-19

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A check-in station at the pop-up vaccine clinic at Sunnyside Community Services on May 17.

On May 27, VIP StarNetwork, an on-demand health services company primarily for entertainment industry workers, hosted a one-day pop-up vaccine clinic at Sunnyside Community Services for one day. The May 27 pop-up vaccine site was Sunnyside Community Services’ first, and the organization has scheduled second-dose appointments for June 17.

Johonniuss Chemweno, the CEO of VIP StarNetwork, said the group has been working with the state government to bring pop-up clinics to diverse and low-income communities. VIP StarNetwork, which had been approved as a mass vaccination provider by a federal agency in February, had previously enforced COVID-19 safety protocols for Netflix and Amazon studios.

The pop-up vaccine clinic had a team of more than a dozen nurses ready to help walk-in visitors get a vaccine. The site allowed all adults and people aged 12 to 18 to get a Pfizer, Moderna, or Johnson & Johnson vaccine.

Chemweno told Insider he’s seen an uptick in people under 18 coming into pop-up vaccine sites. The US began inoculating teenagers with the Pfizer vaccine in May.

Recipients were allowed to choose which vaccine they got depending on availability, Chemweno said.

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Valentina Valencia, an emergency medical technician, and Sofia Mejia, a registered nurse check-in community members for their vaccine jabs.

Nada Elrakaivy, a COVID Free Queens Coalition outreach specialist, told Insider many community members have been hesitant about receiving a Johnson & Johnson vaccine after the CDC reported a rare blood clot had been linked to six vaccine recipients. The welcome sign outside the vaccine clinic noted noted that the site had Pfizer vaccines, and two community members asked specifically for the Pfizer vaccine when entering the pop-up site.

Community members entered Sunnyside Community Services and checked-in with Valentina Valencia, an emergency medical technician, and Sofia Mejia, a registered nurse. The two said they had enjoyed “giving back to the community that needs it” through working at with Sunnyside Community services.

After checking in, a nurse administered the vaccine to community members, and recipients had to wait about 15 minutes for observation before leaving.

Elrakaivy said her group has been giving out free masks to Queens residents on the streets, and providing them with information on how to get a COVID-19 test and vaccine. The COVID Free Queens Coalition took down the names of food vendors, who Elrakaivy said are high-risk due to interacting with many different people daily, and made vaccine appointments for those who were interested.

vaccines pop up clinic sunnyside queens
Nada Elrakaivy, a COVID Free Queens Coalition outreach specialist, told Insider many community members have been hesitant about receiving a Johnson & Johnson vaccine.

The team always has a Spanish-speaking person with them to communicate with the area’s Latino community.

“For the most part, every time we ask someone if they got the vaccine, they responded with a yes,” Elrakaivy said. “So Queens is doing pretty well. Better than we expected.”

How Sunnyside Community Services workers are dealing with vaccine hesitancy

Jonah Gensler, the associate executive director of Community Services, told Insider he had been engaging with the community throughout the pandemic.

Prior to the pandemic, Sunnyside Community Services held services for senior citizens, English classes for immigrant residents, and other programs for vulnerable people across Queens. Gensler said the non-profit reached with homebound seniors using their phone numbers gathered at previous Sunnyside Community Services events.

Read more: Well-funded healthcare startups are snatching up smaller companies to keep growing. It’s the start of a consolidation tsunami.

The group set up a food pantry when the pandemic hit to help struggling community members. Community Services has also hosted online town halls to get the word out about COVID-19 safety, Gensler said.

Gensler said a roadblock to getting community members vaccinated has been the hesitancy around getting a vaccine and distrust in the government, especially after wealthier areas got better access to vaccines than communities that had suffered during the height of the pandemic.

“We have heard that some community members say, ‘You know, at the height of this pandemic, when the communities in Elmhurst and Corona and Jackson Heights were suffering the most, we didn’t get all the support we needed,'” Gensler said. “And that does lead to hesitancy.”

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Nurses wait to administer vaccine jabs to recipients at Sunnyside Community Services

But Lopez, the lead organizer of COVID Free Queens Coalition, said Sunnyside Community Services is uniquely positioned to increase interest in vaccines due to its active members.

She said when one community member said they were hesitant about the vaccine at a recent town hall, other community members chimed in to explain why they got the shot. One person took the vaccine to make sure a senior citizen they care for is safe, Lopez said, and one mother said they want to make sure their child is cared for.

“For us, the biggest goal is kind of bringing up those voices and those stories of why people decided to take the vaccine so that other people who are so a little bit more hesitant will be able to make those connections as well,” Lopez said.

Read the original article on Business Insider

Coronavirus vaccines may be slightly less effective for women than men, emerging research suggests

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A physician administers the Moderna COVID-19 vaccine.

Anna Kern, a 33-year-old nurse practitioner in Ferndale, Michigan, didn’t expect to get COVID-19 after being vaccinated. She got her shots in January, but then in April, she tested positive after being exposed to the virus through an unvaccinated coworker. She has had chills, fatigue, and a racing heart ever since.

“You feel lots of guilt – like, what did I do wrong? How could I have been more cautious?” Kern told Insider, adding, “It feels weird to be a statistical anomaly.”

Breakthrough infections – cases of COVID-19 diagnosed at least two weeks after someone is fully vaccinated – are indeed rare. Just 0.01% of vaccinated Americans had developed breakthrough infections as of April 30, according to a recent report from the Centers for Disease Control and Prevention. But the CDC data suggests that women represent a majority of these cases: 63%.

That’s consistent with clinical trial data, which suggests that coronavirus vaccines are slightly less effective among women. Pfizer’s COVID-19 vaccine was found to have a 96.4% efficacy rate in men, but 93.7% in women. Its widely cited 95% efficacy rate is an average of those two results.

Moderna’s vaccine, meanwhile, was found to have a 95.4% efficacy rate in men, but 93.1% in women. And Johnson & Johnson’s shot reduced the risk of moderate to severe COVID-19 by 68.8% in men, but 63.4% in women.

Together, these results are “a bit perplexing,” Sabra Klein, co-director of the Johns Hopkins Center for Women’s Health, Sex, and Gender Research, told Insider.

Normally, women mount stronger immune responses to vaccines than men do, which often leads to greater protection. Scientists suspect that higher levels of estrogen play a role in this, since estrogen stimulates the immune system.

Klein has a theory as to why that same pattern isn’t playing out for the coronavirus vaccines: It’s possible the shots might be less effective against coronavirus variants for women than for men. Five “variants of concern” have caused the majority of breakthrough infections in the US.

Vaccines train the body to recognize the original coronavirus identified in Wuhan, so they might still work well against that strain in women.

“The whole basis of vaccination is to have some memory cells so that, should you get infected with the virus, if it’s even possible to get for you to get infected, you would be asymptomatic as opposed to being symptomatic because your immune system’s already been trained,” Klein said. “So it might be that some of that training and the specificity of that training is greater for females than males.”

There are, of course, other possible explanations. More women than men have been vaccinated so far, and women could be more inclined to seek out COVID-19 tests or report their illness if they’re experiencing breakthrough symptoms. Women also represent the majority of healthcare workers, who are regularly screened for coronavirus infections at work. So it’s possible that the vaccines won’t turn out to be less effective among women after all.

But it’s hard to determine the answer, Klein said, without more data on how each sex is responding to vaccines.

“The biological differences between males and females and how this could be playing out in response to these vaccines has really not received adequate attention,” she said. “I definitely don’t think these kinds of things should be ruled out – and that’s often what happens because it’s easier to think this is reporting bias than something real.”

Age could also influence vaccine efficacy in women

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Lisa Taylor receives a COVID-19 vaccine in Hollywood, Florida, on August 7, 2020.

Few real-world studies have examined the effectiveness of coronavirus vaccines among men versus women in great detail, so scientists are hesitant to say whether women are more likely to develop breakthrough infections.

“While the overall percent of reported breakthrough infections was higher in women, we do not know the sex-disaggregated numbers for the severity of these infections,” Vaishali Moulton, an assistant professor of medicine at Beth Israel Deaconess Medical Center, told Insider.

Researchers also don’t know whether vaccine effectiveness is particularly low for women in a certain age bracket.

On average, people who have experienced breakthrough infections are between 40 and 74 years old, the CDC report found. Most women undergo menopause between 40 and 60 – so that could partly explain why vaccine efficacy was lower in that group.

“We know that some of the female immunity definitely declines post-menopausally and is associated with a reduction in estrogen,” Klein said.

Since no mRNA vaccine had been authorized before last year, scientists are also considering whether the platform itself might stimulate different immune responses in each sex.

A new study suggests that men and women may respond differently to the lipid molecules that mRNA vaccines use to deliver coded messages to the body. The researchers found that natural killer cells – a type of immune cell that helps fight off infection – absorbed fewer lipid molecules in female blood samples than in male samples.

Klein said it’s important to explore these sex-based differences quickly, since more breakthrough infections could allow the pandemic to stretch on.

“If we don’t have good efficacy of this vaccine in all people, two things are going to happen,” Klein said. “You’re going to have these breakthrough cases and we are not going to be able to really stop the spread as much as we hope we will. You’re also going to start to lose public trust.”

Vaccine trials have a history of focusing on men

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A pregnant woman receives a vaccine.

Vaccine trials have a long history of focusing on male participants. US trials weren’t legally required to enroll women until 1993, when Congress passed the National Institutes of Health Revitalization Act.

Prior to that, women were often left out of medical research because doctors and scientists were concerned that experimental drugs could pose a health risk to babies if a woman became pregnant during a study. Researchers also worried that women’s fluctuating hormone levels could complicate trial results. In 1997, the Food and Drug Administration even recommended excluding women of reproductive age – as well as women who were single, used contraception, or whose husbands had gotten a vasectomy – from early-stage drug trials.

In general, today’s clinical trials often prefer to enroll women taking birth control due to similar concerns about pregnancy, Klein said. Many early-stage vaccine trials also default to using exclusively male mice to avoid having to factor in hormonal differences between the sexes. But even when female participants are included in trials, Klein said, there’s no requirement that the results be analyzed separately for men and women.

That often means that women don’t receive the ideal vaccine dose: Women only need half the standard dose of the seasonal flu vaccine, for instance, to generate the same amount of protective immunity as men do. As a result, women are more prone to adverse reactions from drugs or vaccines. A report last year found that women experience adverse drug reactions nearly twice as often as men do.

Some of these issues could be playing out now with coronavirus vaccines.

The vaccines’ early-stage trials included female animals, and human trials enrolled a relatively equal share of men and women. But the trials didn’t separate data for the sexes when it came to side effects, and pregnant women were excluded.

“Whether you’re talking about male-female differences, or you’re talking about pregnancy, a lot of this could have started in preclinical studies in order to just test some of these things,” Klein said. “All too often, the dogma is that biological sex isn’t important in this context.”

Real-life data has also revealed that women tend have more severe side effects after their coronavirus shots than men do. A February report found that roughly 79% of instances of vaccine side effects reported to the CDC came from women, though just 61% of doses were administered to women overall.

Women also represent the majority of people who experience adverse reactions to coronavirus vaccines, including rare blood clots and anaphylaxis (a severe allergic reaction).

Still, biologists like Klein are hopeful that vaccine researchers will begin studying female subjects more closely in the near future.

“If there’s one silver lining of the pandemic for people like myself who work in the broader area of women’s health, it’s that it’s finally making it very clear that women’s health extends beyond our reproductive tract and that we really should be studied and compared with men,” she said.

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Teens experience side effects after Pfizer’s shot slightly more than adults do. A chart shows the most common.

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Malikai McPherson, 16, receives Pfizer’s vaccine at a clinic in Melbourne, Florida, on May 17, 2021.

During the initial week of Pfizer’s vaccine rollout for 12- to 15-year-olds, roughly 600,000 adolescents received their first shots.

Scientists expected the vaccine to be effective in young people even before trial results were released – our immune systems get weaker with age, so children and adolescents typically develop strong protection from vaccines. Indeed, Pfizer’s clinical trials showed that the vaccine was 100% effective among 12- to 15-year-olds: Out of more 1,100 adolescents who received the shot, none developed COVID-19.

Moderna, meanwhile, announced on Tuesday that its vaccine was also found to be 100% effective among 12- to 15-year-olds in clinical trials. The immune responses among adolescents appeared comparable to that in adults.

But adolescents seem to develop side effects more frequently after Pfizer’s shot than adults. That’s likely because kids’ immune systems do an excellent job of revving up quickly.

“That feeling of yuckiness and fatigue and fever is your body making a great immune response,” Dr. Sharon Nachman, chief of pediatric infectious diseases at Stony Brook Children’s Hospital, told Insider.

The chart below shows the most common side effects among adolescents and young adults (people ages 16 to 25) after Pfizer’s vaccine, depending on the dose.

For the most part, these side effects aren’t too different from those recorded among older adults.

Fatigue and headaches were more prevalent among adolescents than adults

The most common side effect among adolescents in Pfizer’s trial was injection-site pain: Nearly 91% of 12- to 15-year-olds reported that after either vaccine dose. Fatigue was the second-most common, with 78% reporting the symptom. About 76% reported headaches.

Nearly half of adolescents also reported chills after either dose of Pfizer’s shot, while 42% reported muscle pain. Fever and joint pain weren’t as prevalent, though: 24% and 20% of adolescents reported these side effects, respectively.

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Children ages 12 to 15 get vaccinated at the Cross River Center in Lowell, Massachusetts, on May 13, 2021.

In general, almost all of the vaccine’s side effects were more prevalent among adolescents than adults. About 84% of people ages 18 and older who participated in Pfizer’s clinical trials reported injection site pain, while 63% reported fatigue and 55% reported headaches.

Pfizer’s second shot amplifies an existing immune response, so people typically feel more run-down after that dose. That was true overall for both adults and adolescents in clinical trials. Both age groups also saw the side effects stop within a few days.

Clinical trials are studying the vaccines among kids younger than 12

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A mother with her baby girl awaits her turn to be vaccinated in Sardinia, Italy, on May 15, 2021.

Pfizer’s shot isn’t the first to be distributed to teens – the Food and Drug Administration authorized Moderna’s vaccine for 16- and 17-year olds in December.

Moderna’s chief executive officer, St├ęphane Bancel, said in a statement that the company will ask the FDA to authorize its shot for 12- to 15-year-olds in early June. Johnson & Johnson, meanwhile, started testing its single-dose vaccine in adolescents ages 12 to 17 in April.

Moderna and Pfizer are both still testing their vaccines’ safety and efficacy among younger children. Pfizer expects to have data about its shot’s effectiveness among kids ages 2 to 11 by September, followed by data for children ages 6 months to 2 years in November. Moderna could produce similar data for kids between 6 months and 11 years soon after.

Public-health experts widely agree that vaccinating kids could help the US reach herd immunity – the threshold beyond which the virus can’t spread easily from person to person – much faster.

“As you have new children enter the population, they’re going to be susceptible,” Rahul Subramanian, a data scientist at the University of Chicago, told Insider. “When we vaccinate children, it helps us maintain herd immunity.”

This story has been updated with new information. It was originally published on May 19, 2021.

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Moderna says its coronavirus vaccine is effective in teens, and the biotech plans to apply in early June for an expanded OK

Coronavirus vaccine Moderna trial college students transmission study
A coronavirus vaccine trial volunteer receives a shot.

  • Moderna’s coronavirus vaccine likely works in teens, according to study results that the biotech plans to submit to regulators next month.
  • The vaccine could become the second OK’d for people as young as 12.
  • Teens in Moderna’s study had similar immune responses as adults who received the shot.
  • See more stories on Insider’s business page.

Moderna’s coronavirus vaccine appears to be highly protective in 12-to-17-year-olds, the Massachusetts biotech said Tuesday in a press release, paving the way for the shot to be given widely to adolescents as soon as next month.

If regulators give the green light, Moderna’s vaccine would be the second COVID-19 shot to be authorized for people as young as 12, after the Pfizer-BioNTech vaccine. Both vaccine developers are studying their shots in even younger populations.

Read more: One slide lays out Pfizer’s busy 2021 plans for its COVID-19 vaccine, including when it could start being used in kids

Moderna enrolled more than 3,700 people between the ages of 12 and 17 in a clinical study. Two-thirds of the volunteer received two doses of Moderna’s vaccine. The other third received placebo injections.

Adults and children had similar immune responses to the shot, Moderna says

The main goal of the study was to measure the immune responses of participants, comparing their reactions to what was seen in adult volunteers. Moderna said Tuesday the study was successful in showing those immune responses were comparable between age groups, and that it plans to submit that information to regulators early next month.

Pfizer and BioNTech used a similar study to win authorization from the US Food and Drug Administration to provide their shot to adolescents.

The Moderna study counted how many people got sick with symptomatic cases of COVID-19, starting two weeks after the second vaccine dose. Four adolescents had COVID-19 cases in that period, and all of them received the placebo.

The study’s results have not yet been published in a peer-reviewed medical journal.

Moderna described the safety and tolerability of the vaccine as “generally consistent” with the adult trial. The most common side effects after the second shot were headache, fatigue, muscle pain, and chills.

Read the original article on Business Insider

The US will send 13% of its vaccine supply overseas in the next 6 weeks, after the WHO said the world faces ‘vaccine apartheid’

Biden
President Joe Biden.

The US will send 80 million coronavirus vaccine doses, or 13% of its total supply, abroad by the end of June, President Joe Biden said on Monday. That’s five times more doses than any other country has shared with the world so far.

The announcement came shortly after the World Health Organization criticized wealthy nations for stockpiling doses.

WHO Director-General Tedros Adhanom Ghebreyesus said last week that wealthy countries had received 83% of the world’s vaccine supply despite making up just 53% of the world’s population. At an event on Monday, Tedros called the situation “vaccine apartheid.”

Biden, too, emphasized the need to share more doses with the world.

“We want to lead the world with our values, with this demonstration of our innovation and ingenuity, and the fundamental decency of the American people,” Biden said at White House briefing on Monday. “Just as in World War II, America was the arsenal of democracy, in the battle against the COVID-19 pandemic, our nation is going to be the arsenal of vaccines for the rest of the world.”

But the US won’t be redistributing doses that might have otherwise gone to eligible Americans.

The US expects to have have enough doses for everyone who’s eligible (people ages 12 and up) within the next six weeks. As of tomorrow, Biden said, 60% of American adults will have already received at least one shot.

The Biden administration’s plan is to allocate 20 million leftover doses of Pfizer, Johnson & Johnson, and Moderna shots to other countries. The US will also donate 60 million AstraZeneca shots – all the AstraZeneca doses the country has produced thus far – overseas.

The Biden administration hasn’t said which countries will receive the new shipments yet, but the US already promised 4 million AstraZeneca doses to Canada and Mexico.

AstraZeneca’s shot is currently being administered in 165 countries. But the US Food and Drug Administration hasn’t authorized the vaccine yet because it’s waiting on the results of a domestic trial, which was delayed for nearly seven weeks in the fall because of an adverse reaction in a UK participant.

The US purchased 300 million doses of AstraZeneca’s shot roughly a year ago as part of its strategy to buy up multiple vaccine candidates before it was known which ones would be effective. By buying lots of different vaccines ahead of time, the logic went, the US would ensure it had doses of an effective vaccine as early as possible.

Before Monday’s announcement, the Biden administration had already pledged to donate the 60 million AstraZeneca doses, but the vaccines still need to pass an FDA safety review before they’re shipped.

The US vaccine rollout is far ahead of other countries

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People wait to receive COVID-19 vaccines at HB Kanwatia Hospital in Jaipur, Rajasthan, India, on April 11, 2021.

Biden made his announcement at a moment when the US outbreak appears to be turning a corner: For the first time in the pandemic, coronavirus cases are declining in all 50 states. Coronavirus deaths are also at their lowest level since April 2020, Biden said. The CDC reported 415 COVID-19 deaths on Saturday.

But many public-health experts have warned that the US will continue to be vulnerable to future outbreaks if other countries are only vaccinating their populations at low levels. India and Russia, for instance, have vaccinated just around 10% of their populations, while Japan has vaccinated less than 4%.

As long as the coronavirus is spreading, it can mutate – so new variants may continue to arise. Though current vaccines seem to hold up well against existing variants, public-experts worry that a future variant could be far more resistant to vaccine protection.

“We know that America will never be fully safe until the pandemic that’s raging globally is under control,” Biden said on Monday.

Because of this, some experts even think the US should help other countries vaccinate their residents before immunizing its own teenagers.

“To get back to ‘normal,’ we need to immunize our younger people,” Janet Englund, a professor of pediatric infectious diseases at Seattle Children’s Hospital, previously told Insider. But she added that “if we don’t take care of the rest of the world, it’s going to be a temporary fix.”

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Companies across the US are offering workers perks for getting the COVID-19 vaccine. Here’s the running list.

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ICU nurse Megan Tschacher shows off her vaccination card at UC Health Poudre Valley Hospital in Fort Collins, Colorado on December 14, 2020. Helen H. Richardson/MediaNews Group/The Denver Post/Getty Images

  • Workers across the US can receive extra pay from their employers for receiving the COVID-19 vaccine.
  • Many front-line workers are now able to receive the vaccine in various states and localities.
  • So far, almost 34 million people have received one or more doses of the two-shot immunization.
  • Visit the Business section of Insider for more stories.

Companies across the US are joining in the largest-ever vaccination effort by offering employees perks if they receive the two-dose COVID-19 vaccine.

Receiving the vaccine is voluntary, but most companies have strongly encouraged employees get the immunization when it’s their turn. The two-dose vaccines, one from Pfizer and BioNtech and the other from Moderna, were emergency approved in the US in December. Since then, almost 34 million people have received one or more doses, according to data from the Centers for Disease Control and Prevention.

Many states and localities have begun moving from the first phase of vaccinating health care workers and elderly living in long-term care facilities to immunizing front-line workers. With that, some companies are giving workers two to three hours of paid time off per dose received, and others are offering a stipend for employees who voluntarily get the shots when it’s their turn.

Recently, Publix, Petco and AT&T joined the growing list. Here’s the 18 Insider knows about so far:

Know of a company not on this list that’s offering employees time off, pay, or other perks to get vaccinated? Email Natasha, the reporter of this piece, at ndailey@insider.com.

1. Target

Target
Eduardo MunozAlvarez/VIEWpress via Getty Images

Target is offering workers up to four hours of paid time off to get both shots of the vaccine and will pay for Lyft rides up to $15 for employees needing transportation to and from their appointment.

2. Dollar General

dollar general
Justin Sullivan/Getty Images

The discount chain was the first major retailer to announce an incentive for workers to get vaccinated. Dollar General employees can earn up to four hours of pay for receiving both doses of the COVID-19 vaccine and will receive extra time off if they have an adverse reaction.

Read more: What’s coming next for COVID-19 vaccines? Here’s the latest on 11 leading programs.

3. Darden Restaurants

olive garden
Patrons enter an Olive Garden Restaurant. Steve Helber/AP Photo

Darden Restaurants, which owns Olive Garden, LongHorn Steakhouse, Bahama Breeze, and The Capital Grille, will offer workers four hours of paid time off, two hours per dose, Bloomberg reported. Employees must show proof of their vaccination to earn the time. The company doesn’t require the shots, but strongly encouraged workers to get them.

4. Shake Shack

shake shack
Noam Galai/Getty Images

The burger-and-shake restaurant chain will give workers 3 hours of pay per shot of the two-dose vaccine. Shake Shack didn’t mandate employees receive the vaccine but “strongly encouraged” it.

5. Noodles & Company

Noodles & Company.
Noodles & Company.

Workers will earn up to four hours of paid time off for receiving the vaccine, the company said in a Feb. 10 statement to Insider. The restaurant strongly recommended employees receive the vaccine but did not require it.

6. Kroger

kroger
Kroger logo is seen at one of their stores in Athens, Ohio. Stephen Zenner/SOPA

The grocer is giving employees a one-time $100 payment for getting the vaccine. On top of that, Kroger said it would give associates an added bonus of a $100 store card and 1,000 fuel points to “thank and reward” workers during the pandemic.

7. Trader Joe’s

Trader Joe's.
Joe Raedle/Getty Images

The grocery retailer will offer all 50,000 employees two hours of pay per dose and allow for flexible scheduling so workers can make it to appointments.

8. Aldi

Aldi store shop
Matthew Horwood/Getty Images

The German grocer will cover employee costs associated with receiving the vaccine and provide two hours of pay for each of the two doses received.

9. Instacart

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SOPA Images/Getty Images

The app will offer its US and Canada shoppers, who deliver groceries to customers, a $25 stipend to get vaccinated.

10. Lidl

lidl
Leonhard Foeger/File

The German grocery chain is encouraging workers to get vaccinated by offering its US workers $200 in extra pay if they receive the immunization.

11. McDonald’s

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Scott Olson/Getty Images

The fast food chain is giving workers four hours of pay for receiving the vaccine. Though getting the shots is not required, the company said it will connect employees with groups that can answer questions on the vaccination, Restaurant Business reported.

12. Starbucks

starbucks barista drinks
Richard Drew / AP Photo

The coffee chain is offering workers two hours of pay per dose of the COVID-19 vaccine they receive.

13. Chobani

Chobani Greek Yogurt
Sarah Schmalbruch / INSIDER

Chobani will give workers up to six hours of pay, three per dose, for receiving the vaccine, Human Resource Executive reported.

14. Amtrak

Amtrak
AJ Packer/Shutterstock.com

Amtrak is allowing employees to get vaccinated during work hours, and will pay for two hours off if employees provide proof they received the shot. Workers will also be excused with pay for up to 48 hours if they have side effects.

15. JBS USA and Pilgrim’s

jbs meatpacking greely colorado
The JBS meatpacking facility in Greeley, Colo. Chet Strange for The Washington Post via Getty Images

The meat-packing company is offering employees a $100 bonus incentive if they receive the vaccine voluntarily.

16. Petco

petco groomers
Petco groomers. AP Photo/Richard Vogel

The pet-supply retailer told Insider it would offer employees a one-time payment of $75 for getting vaccinated. Plus, it will give a $25 donation to the Petco Partner Assistance Fund for each person who receives their shots.

17. AT&T

AT&T
People walk past the AT&T store in New York’s Times Square, June 17, 2015. Brendan McDermid/Reuters

AT&T is giving employees up to four hours of paid time off per dose, adding up to eight hours total for anyone who needs the hours to get the vaccine, a spokesperson said in an email to Insider. The company is also giving workers access to Castlight, a tool to help them find available vaccines in their area based on eligibility.

18. Publix

Publix grocery store night
Johnny Louis/Getty Images

Publix will give associates a $125 gift card to the store after they get both doses of a COVID-19 vaccine. Workers aren’t required to get the shots at Publix, but they will need to show proof of vaccination. The vaccine is optional, though encouraged, the company said.

19. Walmart and Sam’s Club

Walmart

Beginning May 18, Walmart and Sam’s Club will give its associates below the store manager level $75 for being fully vaccinated, the companies announced on May 14. Workers are required to show their vaccine card in order to receive this bonus.

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Coronavirus vaccines are exceeding expectations in the real world – even in the face of variants

woman getting vaccine
A physician injects a patient with the Moderna COVID-19 vaccine.

  • Coronavirus vaccines are proving just as effective in real life as they were in clinical trials.
  • That indicates that the vaccines are holding up well against variants.
  • In Pfizer’s case, the shot also seems to yield fewer side effects than in clinical trials.
  • See more stories on Insider’s business page.

By the time coronavirus vaccines were rolled out to the public, tens of thousands of people had already received their shots in clinical trials.

The results of those studies gave us a good sense of how well the vaccines worked: Pfizer’s was found to reduce the risk of getting COVID-19 by 95%, while Moderna’s had an efficacy of 94.5%. Johnson & Johnson’s single-dose shot, meanwhile, was found to cut the risk of infection by 66% globally – and by 72% among US trial participants.

But the three trials were difficult to compare side by side, since they happened at different stages in the pandemic and in different geographic regions.

Now, real-world studies are beginning to offer a clearer picture of how well the vaccines perform outside trials and in the face of emerging variants.

For the most part, it’s great news: Pfizer and Moderna’s vaccines seem to be just as effective in real life as in their trials. Recent studies have also found that both shots prevent asymptomatic infections, a result that wasn’t yet known when the trial data came out.

A March report from the Centers for Disease Control and Prevention found that Pfizer and Moderna’s shots were, as a whole, 80% effective at preventing coronavirus infections – with or without symptoms – after just one dose, and 90% effective after two doses.

Similarly, an Israeli study found that Pfizer’s vaccine was 94% effective against asymptomatic infections. That’s likely a sign that the shots reduce transmission.

variant lab
Researchers sequence coronavirus samples at the microbiology laboratory of the University Hospital of Badajoz in Spain, April 15, 2021.

J&J’s shot also seems to be matching its trial results in real life.

A recent study, which is still awaiting peer review, found that J&J’s shot was about 76% effective at preventing all coronavirus infections. (Clinical trials suggested it was 74% effective at preventing asymptomatic infections.)

But the study’s sample size was small: around 1,800 patients observed at The Mayo Clinic from February to April. Just three of those individuals tested positive for the coronavirus 15 days or more after getting vaccinated.

Vaccines are holding up well against variants

As coronavirus variants began to circulate widely in December, some scientists worried that Pfizer’s or Moderna’s shots would stop performing as well as they did in the summer and fall. That’s because the companies’ late-stage trials took place from July to November, when new coronavirus variants weren’t as prevalent.

By contrast, J&J’s late-stage trial took place slightly later in the pandemic, from September to January. The trial also included participants who got infected with B.1.351, a variant first identified in South Africa. The variant has been shown to partially evade antibodies generated in response to vaccines or prior natural infections.

But a large study of Pfizer recipients in Israel suggests that new variants haven’t diminished the vaccine’s effectiveness. From January to March, the Israel Ministry of Health collected data from millions of people who were vaccinated with Pfizer’s shot. By that time, B.1.1.7, a more contagious variant first discovered in the UK, was the dominant strain in Israel.

Pfizer’s vaccine was still found to be at least 97% effective against symptomatic COVID-19 cases, hospitalizations, and deaths.

Israel vaccine injection
Staff of the Maccabi Health vaccination center administer Pfizer doses inside a mall parking lot in Tel Aviv, Israel on January 26, 2021.

Pfizer’s shot has also performed well against variants in Qatar: New research found that people in Qatar who were fully vaccinated with Pfizer’s shot were 75% less likely to get a COVID-19 case caused by the B.1.351 variant than unvaccinated people were. They were also around 90% less likely to develop COVID-19 caused by the B.1.1.7 variant discovered in the UK.

“The vaccines that we have so far seem to be effective against most of the variants, if not all the variants, they’ve really been tested against,” David Dowdy, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health, told Insider.

Pfizer’s side effects may be less common in real life

johnson & johnson vaccine line
Kristine Ko, right, waits in line for her vaccine at a walk-up mass vaccine site in Los Angeles, California, on April 8.

Coronavirus vaccines have generally produced mild, short-lived side effects both in and out of clinical trials. But emerging evidence suggests that Pfizer’s side effects may be less common in real life.

Around 63% of participants in Pfizer’s clinical trial reported fatigue, while 55% reported headaches and 38% reported muscle pain. But after 28,000 Pfizer recipients recorded their side effects in an app, UK researchers analyzed the data and found that less than 15% of people reported fatigue after either their first or second dose. Similarly, less than 14% of the people self-reported headaches and 5% or less reported muscle pain after either their first or second dose.

In J&J’s case, however, rolling out the vaccine to the public revealed a very rare side effect that wasn’t spotted in clinical trials. As of Wednesday, the CDC had identified 28 cases of thrombocytopenia syndrome – a rare combination of blood clots and low platelet counts – among 8.7 million recipients of J&J’s vaccine.

“When you start vaccinating people, you have a much, much, much larger sample size – in the millions,” Dr. Vivek Cherian, an internal-medicine physician in Baltimore, previously told Insider. “So when you have these exceedingly rare complications, sometimes you don’t see that until you actually start.”

Since the clotting cases are around 3 in 1 million so far, the CDC has said the benefits of J&J’s shot far outweigh the risks. But the vaccine’s label now warns that the shot may pose an increased risk of clotting, particularly among women under 50.

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Moderna stock plummeted on Biden’s support of waiving vaccine patent protections, but that backing won’t have a material impact on the company, Morgan Stanley says

Moderna covid vaccine coronavirus
Moderna’s COVID-19 vaccine won emergency use authorization from the FDA in December 2020.

  • Moderna shares have dropped sharply since the Biden administration on Wednesday voiced support for waiving patent protections on COVID-19 vaccines.
  • Morgan Stanley said it doesn’t see the US’s waiver support as having a material impact on Moderna’s business.
  • Moderna’s management had indicated it wouldn’t enforce its vaccine patent during the pandemic, says Morgan Stanley.
  • See more stories on Insider’s business page.

Moderna shares fell sharply for a second session Thursday after the US said on Wednesday it supports waiving intellectual property protections for COVID-19 vaccines. The stock has now declined as much as 23% since Monday’s close after a 7% drop on Tuesday.

But Morgan Stanley said it doesn’t see a waiver materially hurting the biotech company’s business.

The Biden administration supports a waiver “in service of ending this pandemic,” even as it “believes strongly in intellectual property protections,” US Trade Representative Katherine Tai said in a statement Wednesday.

A waiver would allow other countries to make vaccines from Johnson & Johnson, Pfizer, and Moderna without fearing sanctions at the World Trade Organization.

While the US’s waiver support generates “a negative headline, we believe the practical impact is limited,” on Moderna’s business, said Matthew Harrison, an equity analyst at Morgan Stanley, in a note published Thursday.

He said Moderna’s management had previously indicated it wouldn’t enforce its intellectual property patent during the pandemic. Meanwhile, the investment bank said it doesn’t believe the WTO has any mechanism to force Moderna’s management to teach other manufacturers how to make its vaccine, which suggests no change in the status quo.

“Finally, we believe any new manufacturing operation could take 6-9 months to scale, effectively limiting the impact of other manufacturers,” wrote Harrison.

Shares of Pfizer were off by nearly 3% on Thursday and BioNTech was down by more than 2%.

“You have this political pressure to share patents with every pharmaceutical company. Then you have the other side of it, which is these pharmaceutical companies need to be motivated to always do research and development. Even though there was a pandemic and a humanitarian crisis, there is still a cost,” Hilary Kramer, chief investment officer at Kramer Capital Research, told Insider.

“Whether it’s Pfizer or Moderna or BioNTech, they have a responsibility to their shareholders and they also have a responsibility to continue to have a pipeline of products and to know [that R&D] is going to pay off,” she said. “We need to watch that – that could have a greater impact on pharmaceutical stocks.”

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We just got our first evidence that Moderna’s coronavirus booster shot works to fight variants

Moderna vaccine
A lab tech processes blood samples from participants in Moderna’s coronavirus vaccine clinical trials in Miami on September 2.

  • Moderna said Wednesday that a third dose greatly boosted antibody levels in volunteers in a study.
  • This updated vaccine, tailored against the B.1.351 variant, worked best, the company said.
  • These are the first clinical results from any vaccine developer testing an updated COVID-19 shot.
  • See more stories on Insider’s business page.

Moderna is voicing confidence in a new version of its coronavirus vaccine tailored to fight variants of the virus. The biotech on Wednesday released data from a clinical trial testing its booster doses.

These are the first clinical results from any vaccine developer testing an updated COVID-19 shot. Moderna started new research earlier this year to see if it could develop a booster shot that would better protect against the B.1.351 variant first found in South Africa.

Earlier research, done in petri dishes, suggested the B.1.351 variant was able to partially reduce the effectiveness of leading vaccines, including from Pfizer and Moderna. This means the current shots likely still work against these variants, but experts caution it’s less clear how long that protection will last.

The positive findings could support the rollout of variant-specific booster doses, potentially as soon as the end of 2021 or 2022 in some countries, Moderna executives recently said.

While no one knows exactly when booster shots would be needed, experts generally think the presence of variants that can partially degrade the efficacy of vaccines will speed up the need to give additional shots, particularly for the most vulnerable populations.

Researchers tried 3 different kinds of boosters in the clinical trial

In this new clinical trial, Moderna tested a third dose on people who had previously gotten the two-dose vaccine six to eight months ago.

These study volunteers received one of three options: another dose of Moderna’s original vaccine, this new version tailored to the B.1.351 variant, or a multivalent version that contains a 50-50 mix of the original and B.1.351 vaccine versions.

In a Wednesday press release, Moderna described initial results from the original vaccine and the B.1.351 shot. The company plans to later report on the multivalent version, as well as testing an even lower dose strength of 30 micrograms. The research has yet to be published in a peer-reviewed medical journal, and Moderna said it has submitted the paper to a preprint server.

Before getting the third dose, Moderna tested volunteer blood samples to see how durable the vaccine response has been through six to eight months. While 37 of the 40 people had detectable levels of antibodies, the virus-fighting proteins that are the backbone of our immune response, only about half of the participants had detectable level of antibodies against B.1.351 and P.1, the variant first identified in Brazil.

One booster shot was most effective and led to fewer reactions

The study found those who were given the B.1.351-specific booster had the most effective immune response. Antibody levels were about 62% higher in that group, compared to those given another dose of Moderna’s original shot.

“We are encouraged by these new data, which reinforce our confidence that our booster strategy should be protective against these newly detected variants,” Moderna CEO St├ęphane Bancel said in a statement. “The strong and rapid boost in titers to levels above primary vaccination also clearly demonstrates the ability of mRNA-1273 to induce immune memory.”

Moderna said the booster shots were well tolerated overall, with people having reactions similar to those seen after the second dose.

The B.1.351 booster shot appeared to produce slightly less severe reactions overall, Moderna said. About 11% getting the 351-specific booster reported a grade-three adverse event, which is severe enough to impact daily living activities, compared to 15% who got the a third dose of the original shot.

The most common side effects were fatigue, headache, muscle pain, and joint pain.

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