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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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.

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Sanofi and GlaxoSmithKline say their COVID-19 vaccine triggers a strong immune response, bolstering the late-comer program’s potential as a booster shot

FILE PHOTO: Paul Hudson, chief executive officer of Sanofi, poses during the annual results news conference in Paris, France, February 6, 2020. REUTERS/Benoit Tessier
Sanofi CEO Paul Hudson

  • Sanofi and GlaxoSmithKline said that their experimental COVID-19 vaccine succeeded in a mid-stage trial.
  • The pharma giants plan to launch a pivotal-stage study with 35,000 volunteers in the coming weeks.
  • The shot suffered from disappointing data and delays in 2020. The companies now hope for approval by year’s end.
  • See more stories on Insider’s business page.

One of the world’s most closely watched coronavirus vaccine programs reported positive data on Monday from a mid-stage clinical trial, paving the way for the start of a massive human trial that could allow the shot to be authorized before the end of this year.

Sanofi and GlaxoSmithKline, two of the largest vaccine-makers in the world, said in a press release that their experimental coronavirus vaccine led to strong immune responses across all ages in a study that enrolled 722 volunteers. It’s a much-needed piece of positive news for the two industry leaders, which saw their vaccine effort delayed by disappointing data announced in December, and have fallen far behind rivals like Moderna, Pfizer-BioNTech, and Johnson & Johnson.

Read more: GlaxoSmithKline stumbled with COVID-19 shots. Now it’s facing an exodus of US talent and an uncertain future as the world’s vaccine leader.

The companies did not release specific data on the antibody response, nor did they publish results in a peer-reviewed medical journal or post a paper on a preprint server.

Emma Walmsley
GSK CEO Emma Walmsley

Instead, the companies issued a press release describing the neutralizing antibody responses as “comparable to those generated by natural infection.”

Neutralizing antibodies are the virus-fighting proteins that play a critical role in our immune response. GSK and Sanofi added that younger volunteers had generally stronger immune responses to the vaccine.

The two pharma giants expect to launch a final-stage clinical study, called a Phase 3 trial, in the coming weeks that will enroll more than 35,000 people. They also plan to simultaneously run smaller studies that test their vaccine, including versions tailored to neutralize specific coronavirus variants, as booster shots in people who’ve already been immunized.

If everything goes to plan, Sanofi and GSK expect their vaccine to be approved in October, November, or December of 2021, the companies said.

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The US just authorized Pfizer-BioNTech’s coronavirus vaccine for teenagers, making it the first COVID-19 shot OK’d for 12- to 15-year-olds

16-year-old participates in coronavirus vaccine trial for Pfizer at Cincinnati Children's Hospital, pediatric vaccine studies COVID-19
A 16-year-old in Pfizer’s clinical trial to test its coronavirus vaccine candidate.

  • US regulators have OK’d Pfizer-BioNTech’s coronavirus vaccine for use in younger teenagers.
  • The two-dose shot is the first vaccine to be authorized for use in the 12- to 15-year-old age group.
  • US health officials have said they will soon be ready to start giving the shot to kids.
  • See more stories on Insider’s business page.

Teenagers in the US are now eligible for a leading coronavirus vaccine, as the Food and Drug Administration on Monday expanded the authorization for Pfizer-BioNTech’s COVID-19 shot to include 12- to 15-year-olds.

The two-dose vaccine was approved in December for anyone 16 years old and up. US health officials said they were prepared to soon start giving the shot to younger teenagers.

Canada is the only other country to have OK’d a COVID-19 vaccine for younger teenagers. On May 5, it authorized Pfizer’s vaccine for use among people 12 and older.

Expanding eligibility to include the younger age group could give the immunization campaign a boost. The US has seen the daily rate of people getting their first dose plummet since early April, from a peak of 1.9 million people a day to about 830,000 a day, according to data from the Centers for Disease Control and Prevention.

A major driver for that decline has been that a majority of adults in the US have already received at least one dose. About 58% of US adults have received at least the first dose of a vaccine, according to CDC data.

“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” Dr. Janet Woodcock, the acting commissioner of the FDA, said in a statement. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”

Pfizer tested the vaccine in a clinical study that enrolled 2,260 children ages 12 to 15. Half of the volunteers received Pfizer’s shot, while the other half got a placebo injection. Overall, the trial recorded 18 COVID-19 cases, all in the placebo group. Side effects of the shot were in line with those observed in people 16 to 25 years old, Pfizer said.

Pfizer and other vaccine developers are also testing COVID-19 shots in younger populations down to 6-month-olds

The New York drugmaking giant is still testing the shot in younger ages, hoping to further expand its eligibility later this year.

In September, Pfizer anticipates study results showing whether the shot works in children ages 2 to 11.

The final step down for kids – from 6-month-old babies to 2-year-olds – should produce data in November, according to Pfizer’s projections.

Other leading vaccine developers are also testing their shots in younger populations.

On May 6, Moderna said its vaccine was highly effective in an initial review of a clinical trial enrolling more than 3,000 teenagers. The Massachusetts biotech said it was “in discussions with regulators about a potential amendment to its regulatory filings” after those early results. Moderna is also enrolling volunteers for a study testing the vaccine in kids 11 years old all the way down to 6 months old.

Johnson & Johnson also started testing in April its single-dose vaccine in adolescents 12 to 17 years of age.

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Precipio extends 2-day gain to 404% following launch of the company’s COVID-19 test on Amazon

Traders work on the floor of the New York Stock exchange
  • Precipio shares jumped by more than 400% during a rally that extended for a second day on Tuesday.
  • The surge came after the company’s COVID-19 antibody test started selling on Amazon.
  • The 20-minute test was the first of its kind in the US to win FDA approval for emergency use.
  • See more stories on Insider’s business page.

Precipio stock rocketed higher for a second session on Tuesday, with a fivefold surge in the price ignited after the specialty diagnostics company launched its COVID-19 antibody test on Amazon.

The company said it holds the exclusive rights to distribute the 20-minute test on Amazon’s platform. Precipio said the test, which covers two types of antibodies, was visible for sale on the retailing giant’s website and app.

Precipio shares surged to an intraday high of $9.18 Tuesday, a gain of 404% from Monday’s opening price of $1.82.

The company said the test can currently only be purchased by “qualified” medical point-of-care providers such as physicians and medical facilities.

The test, which is manufactured by Palo Alto, California-based Nirmidas Biotech, was the first one based in the US to receive emergency use authorization by the Food and Drug Administration for point-of-care use, Precipio said.

“We look forward to working with other retail outlets, as well as with Nirmidas to advance this product into at-home use, following the receipt of appropriate FDA authorization,” said Precipio.

Amazon shares were down by 3% as part of a wider selloff on Tuesday.

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Getting AstraZeneca’s shot is safer than flying on a plane, experts say – the bigger problem is an ‘explosion of vaccine skepticism’

Veran France vaccination health minister AstraZeneca
French Health Minister Olivier Veran receives a dose of the AstraZeneca vaccine on the outskirts of Paris on February 8, 2021.

  • Blood clots are a “very rare” side effect of AstraZeneca’s shot, European regulators said Wednesday.
  • But five medical experts told Insider they aren’t convinced the shot actually causes clotting.
  • Experts worry that public skepticism may unnecessarily derail AstraZeneca’s global vaccine rollout.
  • See more stories on Insider’s business page.

The world’s most-administered coronavirus shot is facing what may be its biggest challenge yet.

On Wednesday, European regulatory authorities said potentially fatal blood clots are indeed a rare side effect of AstraZeneca’s vaccine. Following the announcement, the UK’s regulator said people under 30 years old should seek out other shots, if available.

AstraZeneca’s vaccine has already been rolled out to tens of millions of people around the world. In interviews with Insider, five medical experts emphasized that the shot is safe and effective.

“The risk of dying in an air crash is just astronomically higher than the risk of clotting after the vaccine dose, and yet we all get on a plane without a second thought,” Johan Bester, director of bioethics at the University of Nevada, Las Vegas School of Medicine, told Insider.

Wednesday’s announcement came after European medical officials reviewed fewer than 100 blood-clotting cases reported among more than 25 million people in the EU who’ve gotten AstraZeneca’s shot. That’s a rate of roughly 4.6 clot cases per 1 million shots – higher than expected, the review found, but still extraordinarily rare.

Given that, experts are more concerned about the consequences of public suspicion of the shot.

“All that people heard was: AstraZeneca’s vaccine can kill you because of blood clots,” Art Caplan, a bioethicist at New York University, told Insider, referring to the Wednesday announcement. “They’re not watching the fine tuning and the careful recommendations.”

Countries that have authorized the vaccine, he added, are now going to have to deal “with a very huge explosion of vaccine skepticism.”

A non-issue? A blip?

The World Health Organization also issued a note of caution on Wednesday, acknowledging that a relationship between blood clots and the vaccine is “considered plausible but is not confirmed.”

AstraZeneca, meanwhile, said these are “extremely rare events” that have occurred on a minuscule scale.

“There is no proof that the AstraZeneca vaccine leads to blood clots,” Todd Ellerin, director of infectious diseases at South Shore Health in Massachusetts, told Insider. “Association is not the same as causation.”

Alex Spyropoulos, a director at New York’s Northwell Health who specializes in blood clots, told Insider that he, too, is not yet convinced there’s a cause-and-effect relationship.

“This is almost a non-issue, a blip on the safety screen,” Spyropoulos said. “The numbers do not elicit the type of hysteria we are seeing.”

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A vial of AstraZeneca’s shot.

Although even a minuscule chance of a fatal blood clot sounds scary, no medicine carries zero risk. After a year of taking birth-control pills, about one in 1,000 women will develop blood clots. (The risk is about 1 in 10,000 for all young women, so it’s elevated nearly 10-fold in birth-control takers.)

Even other authorized COVID-19 vaccines have faced safety scares. Johnson & Johnson’s trial was paused in October because of an unexplained illness in a study participant. Moderna and Pfizer’s shots also saw scattered reports of severe allergic reactions, but these cases have been extraordinarily rare and manageable.

Taison Bell, an infectious-disease physician at the University of Virginia, noted that the rate of blood clots among AstraZeneca recipients was close to the rate you’d see in a normal population.

“When we look at the risk of death from COVID-19, long haul from COVID-19, versus these very rare side effects, I think the overwhelming pendulum swings towards getting vaccinated,” he said. “I’m not particularly concerned about this announcement.”

Scientists are still studying the association between AstraZeneca’s shot and blood clots, particularly to find out whether certain groups may face higher risk for biological reasons. In the meantime, the public should take comfort in the fact that surveillance systems are working to detect and investigate unusual cases, experts said.

AstraZeneca has struggled with transparency

AstraZeneca CEO Pascal Soriot
Pascal Soriot, CEO of AstraZeneca, testifies before the Senate Finance Committee on February 26, 2019 in Washington, DC.

Wednesday’s concerns about AstraZeneca’s two-dose vaccine are far from its first controversy.

The company’s global trial results puzzled many experts in November, because AstraZeneca combined data from its Brazil and UK groups, even though they had different sample sizes and demographics. It also averaged the results of two different dosing regimens, one of which was administered by mistake.

Subsequent analyses, meanwhile, revealed that the vaccine’s effectiveness could vary dramatically depending on the amount of time separating the two doses. Confusion about this disparate data led to a patchwork of mismatched vaccine authorizations and guidelines around the world.

The new blood-clot reports could make people even less likely to judge the shot on its merits, experts said.

“The perception that this is not as good as the Pfizer or the Moderna shot has taken hold among the public,” Bester said.

Blood-clot concerns are their own ‘worldwide crisis’

AstraZeneca vaccine Ghana 2021
A health worker holds up the AstraZeneca vaccine at the Ridge Hospital in Accra, Ghana, on March 2, 2021.

If countries continue to hold off on administering AstraZeneca’s vaccine to some or all of their populations – or if their citizens refuse to take it – it could slow the global rate of vaccinations. That, in turn, would give the virus more time to develop dangerous mutations.

“When we try to play the game of which one is better, we lose the overall point that they’re pretty much all good and have the potential, when widely deployed, to break the back of the pandemic,” Bell said. “If we have distrust or a preference when there’s not the supply to support preferences, that means on the public-health scale, we’re not globally vaccinating, which means we’re not getting protected.”

AstraZeneca’s vaccine remains the world’s best hope at inoculating lower- and middle-income countries in particular, since the drugmaker has priced its shot far lower than other vaccines and has vowed to produce up to 3 billion doses this year.

That makes the blood-clot concerns “a worldwide crisis” of their own, Caplan said.

“The perception of danger is huge, and I think many people are going to say, ‘I don’t want that,’ or ‘I prefer something else,'” he said. “It’s a big, big setback for those countries that invested heavily in AstraZeneca.”

The US could still authorize the shot

Denmark COVID-19 AstraZeneca
AstraZeneca COVID-19 vaccines in storage in Copenhagen, Denmark on February 11, 2021.

An AstraZeneca spokesperson told Insider that the drugmaker still plans to apply for emergency authorization with the US Food and Drug Administration in the first half of April.

Experts think the vaccine is likely to get a green light, given positive trial results last month, which showed the shot was 76% effective at protecting against symptomatic COVID-19. But the vaccine’s chances of being widely used in the US seem increasingly slim, given the large supply of other authorized vaccines.

Caplan said the FDA would likely take “a much longer and harder look” at the data now, given the blood-clot reports. The agency may even require a year and a half’s worth of data before moving toward authorization, he said.

“At the rate we’re vaccinating right now, we might be all vaccinated by the time this even becomes an issue” in the US, Bester said.

Because of that, many experts have been suggesting the US donate its supply agreement of 300 million AstraZeneca doses to other countries. However, the optics of such a move would be more difficult now.

“I’m sure in retrospect, it will be like, the US is shipping out the inferior vaccine, which is not the case,” Ellerin said. “AstraZeneca is not the inferior vaccine, but it has done just about everything in its power to cause unforced errors.”

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