Fauci said a COVID-19 vaccine will be available to young children in the fall

School children walk with masks and backpacks on.
In this Tuesday, Aug. 10, 2021 file photo, Students, some wearing protective masks, arrive for the first day of school at Sessums Elementary School in Riverview, Fla.

  • Vaccines could be available for use in children under 12 in the fall, Dr. Anthony Fauci said.
  • The Pfizer vaccine will likely become available for young children before the Moderna vaccine, he added.
  • Under an ideal timeline, children could receive the shot by the end of October.
  • See more stories on Insider’s business page.

Dr. Anthony Fauci, the longtime director of the National Institute of Allergy and Infectious Diseases, said Sunday that a COVID-19 vaccine for children under the age of 12 would be available in the fall.

“It will certainly be this fall,” said Fauci, the chief medical advisor to President Joe Biden, during an appearance on ABC News’ “This Week.”

“When you talk about the rollout for vaccines again, there will be a little bit of a different in time frame, maybe a couple of weeks between Pfizer and Moderna and others,” he told ABC News’ Martha Raddatz.

“So, what we’re going to almost certainly see is that sometime in the next few weeks as we get into October, we’ll be able to see the vaccines for children get enough data to be presented for safety and immunogenicity, but when it gets to Moderna, it will probably be a few weeks beyond that, maybe the end of October, beginning to have November,” he added.

He said that the data would likely be available sometime in “mid to late fall” for US officials to make the decision on authorizing a vaccine in use for children aged 11 to five years old.

As Insider previously reported, both Pfizer and Moderna began enrolling children in their vaccine trials in March Moderna previously said it expected to have data about its vaccine’s efficacy in young children in late fall or early winter, while Pfizer planned to have the data ready by the end of September.

It will likely take the US Food and Drug Administration several weeks to review the data before making a final decision on providing the emergency use authorization to use the vaccines.

In a best-case scenario, children aged five to 11 could be eligible to receive the vaccine by the end of October, said former FDA Commissioner Scott Gottlieb, who serves on Pfizer’s board, Insider’s Aria Bendix reported last week In the same best-case scenario, the vaccine could be authorized for use in children 6 months old to 5 years old by late November.

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Pfizer and Moderna have revealed the way they’re tracking how long vaccine protection lasts

A woman receives a COVID-19 booster shot Netanya, Israel, January 19, 2021.
A woman receives a COVID-19 booster shot in Netanya, Israel, on January 19, 2021.

A Friday meeting in Washington got a little messy: An expert panel said the Food and Drug Administration (FDA) shouldn’t green-light Pfizer’s COVID-19 booster shot for the general public – but not without some dissent.

Pfizer executive Dr. William Gruber argued that without booster shots the US could face a wave of infections among the vaccinated. But committee members questioned whether it was too soon to tell if boosters offer any more protection to healthy Americans who’ve already received two doses. Members voted 16 to 3 against recommending Pfizer boosters for people ages 16 and up – but unanimously recommended the shots for adults ages 65 and up or those at high risk of severe disease.

Their debate hinged on a key question: When do the first two shots stop offering enough protection?

This week, Pfizer published its most robust data yet about how long its vaccine protection lasts, with results from at least eight studies. The data showed that the vaccine’s effectiveness fell significantly over time – to 47% efficacy after five months, down from 88% in the month following dose two.

Though Friday’s meeting didn’t evaluate Moderna’s booster, the company released data in a press release on Wednesday that also makes a case for boosters.

Both datasets give a look under the hood at how each company is measuring the duration of vaccine protection. Pfizer and Moderna have been tracking participants from their clinical trials, who are divided into two groups: Those who got vaccines as part of the trials (which began in 2020) and those who got a placebo, then the real vaccine once it was authorized.

Pfizer and Moderna each compared the incidences of breakthrough infections between the two groups. Pfizer’s results showed that the risk of breakthrough infections was 26% lower for trial participants who were fully vaccinated roughly five months prior, compared to those who had gotten their second shot approximately 10 months earlier.

Moderna, similarly, said breakthrough infections were more common among trial participants who got vaccinated between July and October 2020 than among those vaccinated between December and March. The company identified 162 breakthrough infections among those who were fully vaccinated 13 months prior, compared to 88 breakthrough infections among those who had gotten their second shot eight months before.

St├ęphane Bancel, Moderna’s CEO, cited those numbers as support for booster shots.

Vaccine protection seems to wane over time

child Pfizer vaccine
A 12-year-old receives their first Pfizer vaccine dose at a Los Angeles County mobile vaccination clinic on May 14, 2021.

Several recent studies have similarly found that Pfizer’s vaccine effectiveness diminishes over time.

The vaccine’s protection against infection fell from 88% in the month following the second dose to 47% five months after that second shot, according to a study from Kaiser Permanente. And real-world data from Israel suggests that the risk of breakthrough infections is significantly higher for people who were vaccinated with Pfizer earlier in the pandemic than for those who received vaccines later.

The Delta variant may pose a particular challenge. Pfizer’s protection against breakthrough infections fell to 53% four months after it was administered, based on data collected from June to July, when Delta was becoming more prevalent in the US. The company thinks these results are due to waning protection, though – not the variant’s ability to evade vaccines.

Moderna’s data showed a smaller dropoff in efficacy against Delta infections. Another Kaiser Permanente study that’s still awaiting peer review found that Moderna’s vaccine was 87% effective in preventing COVID-19 infections after three months – down from 94% prior to the rise of Delta.

While the Pfizer vaccine remains highly effective against hospitalization and death from COVID-19, a new report released by the Centers for Disease Control and Prevention (CDC) suggests that Moderna may offer better protection against hospitalization. Being fully vaccinated with Moderna lowered recipients’ risk of hospitalization by 93% from March to August, according to the report, compared to an 88% reduced risk of hospitalization among Pfizer recipients.

The report’s findings may “guide individual choices and policy recommendations regarding vaccine boosters,” the CDC authors wrote.

Is it time for boosters yet?

joe biden
President Joe Biden wants to roll out COVID-19 booster shots to most Americans on September 20.

Before the FDA advisory panel made its decision on Friday, the Biden administration had already announced a booster shot campaign for those who’d gotten Pfizer or Moderna. The administration pinpointed September 20 as the date on which most Americans would be eligible for third shots. (The FDA has already authorized boosters for immunocompromised people.)

Dr. William Schaffner, a professor of infectious diseases at Vanderbilt University, questioned whether the White House got ahead of itself.

“This is the sort of internal, behind-closed-doors argument – inside baseball – that goes on in science being translated into public policy all the time,” Schaffner said. “The reason it’s out in the open is because the White House made that pronouncement.”

Protection wanes over times for all vaccinations, he said, and COVID-19 shots were not designed to prevent mild infections, but rather to prevent hospitalization and death – which they do very well after six or eight months.

“Will we need a booster someday?” Schaffner asked. “Sure. Do we need it today? No!”

Schaffner doesn’t begrudge the scientists at Pfizer and Moderna for pushing boosters, though.

“I don’t think this comes out of marketing division of the company,” he said. “I think the scientists really believe it.”

But he noted that many other concerns are at play. For one, two departing FDA regulators, as well as the World Health Organization, have cautioned against offering third shots to the general population while much of the world remains unvaccinated, and without compelling evidence showing the need for extra shots.

Schaffner doesn’t think that global equity argument holds up. He noted that regulatory and distribution challenges would make it difficult for the US’s vaccine surplus to go directly to poorer countries with low vaccine access.

“It’s a false notion that if you don’t give the boosters, those doses will be delivered to Indonesia,” he said, adding, “The problem is that we haven’t gotten a first dose into people. That’s where we ought to put our energy, time, and resources.”

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Moderna’s vaccine offers better protection against COVID-19 hospitalization than Pfizer or J&J, new CDC study finds

Moderna coronavirus vaccine trial college students transmission asymptomatic infection study
Olivia Parsons, 22, a neuroscience major at the University of Colorado Boulder, left, gets her first dose of the Moderna vaccine from Dr. Laird Wolfe.

  • Moderna’s COVID-19 vaccine seems to protect better against hospitalization than other US-authorized shots.
  • Moderna’s shot lowered the risk of hospitalization by 93%, a new CDC report found.
  • Pfizer’s shot lowered that risk by 88%, whereas Johnson & Johnson’s shot lowered it by 71%.
  • See more stories on Insider’s business page.

Until recently, Moderna and Pfizer’s COVID-19 vaccines were seen as comparable shots, offering similar protection against disease and death.

But a new report released Friday by the Centers for Disease Control and Prevention suggests that Moderna’s vaccine does a better job of preventing COVID-19 hospitalizations than other vaccines authorized in the US. Both Moderna and Pfizer’s vaccines, as well as one from Johnson & Johnson, offer substantially better protection than remaining unvaccinated, the report shows.

Moderna’s two-dose shot lowered the risk of hospitalization by 93% from March to August, the report found. Meanwhile, Pfizer’s two-dose vaccine lowered the hospitalization risk by 88% over the same time period.

The report pooled data from 21 hospital across 18 US states. It looked at about 1,300 fully vaccinated people and compared them to about 2,300 people who hadn’t received shots. Of the vaccinated people, 476 got Moderna shots, 738 got Pfizer’s, and 113 received J&J.

The Delta variant became dominant in the US in July, so the data may include people who got infected with Delta, Alpha, or other common strains over the last six months. (The report didn’t screen for individual variants.)

The protection from Pfizer’s shot declines over time

The difference in vaccine effectiveness appears to be driven by the fact that Pfizer’s protection declined over time, whereas Moderna’s did not, the CDC authors wrote. Pfizer’s shot lowered the risk of hospitalization by 91% in the first four months after it was administered. Protection went down to 77% after four months.

Both Moderna and Pfizer’s vaccine soffer better protection than J&J’s single-dose shot, though. That vaccine lowered the risk of hospitalization by 71% over the time period of March to August, the report found. All three vaccines still offer strong protection against severe disease and death.

The findings may “guide individual choices and policy recommendations regarding vaccine boosters,” the CDC authors wrote. Indeed, some public-health experts have suggested that boosters may not be necessary for those who received Moderna’s shot.

“The early evidence looks like persistence is better with Moderna, and that’s why the [Biden] administration and the FDA have been suggesting that it’s really more specific to people who got Pfizer who may need boosting,” Chris Beyrer, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health, recently told Insider.

A Food and Drug Administration external advisory panel is meeting today to decide whether to recommend a third dose of Pfizer’s vaccine.

Moderna’s vaccine also seems to hold up better against Delta infections

Moderna vaccine
A person receives the Moderna COVID-19 vaccine at the East Boston Neighborhood Health Center (EBNHC) in Boston, Massachusetts on December 24, 2020.

The CDC report gives a few reasons for why Moderna’s vaccine seems to offer more lasting protection against hospitalization. For one, the vaccine contains a higher dose of mRNA, which may explain why Moderna’s shot produced higher antibody levels than Pfizer’s vaccine two to six weeks after it was administered.

Moderna’s doses are also given four weeks apart, which may allow more time for antibodies to build. Pfizer’s doses are given three weeks apart.

A recent UK study, which is still awaiting peer review, found that Pfizer’s vaccine may have performed better with a longer dosing interval: The shot seemed to produce more antibodies when doses were administered six to 14 weeks apart as opposed to three to four weeks apart.

Other studies have also suggested that Moderna’s vaccine may do a better job of preventing infections in the face of the Delta variant.

An August study from the Mayo Clinic that hasn’t been peer reviewed found that Moderna’s vaccine lowered the risk of a coronavirus infection by 86% in Minnesota from January to July. In July, when the Delta variant accounted for more than 70% of Minnesota’s COVID-19 cases, that protection went down to 76% – a small decrease compared to Pfizer’s. Pfizer’s shot lowered the risk of a coronavirus infection by 76% from January to July. In July, that protection went down to 42%.

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Moderna says a study showed falling COVID-19 immunity over time and a need for boosters – even though most ‘breakthrough’ infections weren’t severe

Moderna vaccine
University of Miami Miller School of Medicine lab tech Sendy Puerto processes blood samples from study participants in the specimen processing lab, Wednesday, Sept. 2, 2020 in Miami. The volunteers are taking part in testing the NIH funded Moderna COVID-19 vaccine.

  • Moderna said people vaccinated in 2020 caught COVID-19 more often than those vaccinated this year.
  • This suggested immunity from its COVID-19 shot waned over time, and provided evidence for a booster dose, it said.
  • But the number of people that got severe COVID-19 wasn’t significantly different between the groups.

Moderna said new data from its late-stage clinical trial provided proof of waning immunity from its COVID-19 vaccine and a need for a booster dose – but its shot still appears to protect against severe illness.

People who got its vaccine more recently, between December 2020 and March 2021, reported 36% fewer “breakthrough” COVID-19 infections, compared with those vaccinated during its initial trial between July and October 2020, the company said Wednesday, citing an unpublished company analysis.

There were 88 breakthrough cases in the more recently vaccinated group of 14,746 people, and 162 COVID-19 cases in the 11,431 trial participants, eight to 12 months after the second dose, the company said.

Moderna said the findings show evidence of waning immunity from its vaccine, and a “potential benefit” for a booster.

Stephen Hoge, president at Moderna, said on a conference call with investors that “the first six months are great, but you can’t count on that being stable out to a year and beyond,” as reported by Reuters.

He said that “the estimated impact of waning immunity would be 600,000 additional cases of COVID-19” across the US population of 66 million. “We would expect some of those cases to be severe and some could unfortunately result in death,” he said.

But the data also suggested its shot protected against severe COVID-19 long-term. There were only 19 “severe” breakthrough infections overall, and no “significant difference” between the two groups of people, it said. The company didn’t define what it meant by “severe” COVID-19, but usually this means illness that kills or requires hospital treatment.

Mild breakthrough infections are expected with any vaccine because no vaccine is 100% effective.

Moderna’s announcement comes as the Food and Drug Administration (FDA) is soon to decide whether to give an extra dose of Pfizer’s COVID-19 vaccine to fully-vaccinated Americans to shore up immunity against the highly infectious Delta variant, which can evade the immune response.

The FDA is expected to decide on a potential Moderna booster soon after. But some healthcare experts, including Ellie Murray, an epidemiologist at Boston University, have concerns around the quality of data informing the FDA decision: We don’t really know how long booster protection lasts, or when best to give a booster. The World Health Organization argues that we should prioritize people worldwide who haven’t had a first dose before giving boosters to fully vaccinated people.

The Biden administration hopes that fully vaccinated Americans can get a booster dose at six months after their second dose, from September 20. Immunocompromised people in the US can already get an extra shot.

Moderna vaccine’s protection against severe disease

Moderna’s shot has performed better than Pfizer’s in recent lab studies. Some experts speculated that this could relate to the higher dose of the active ingredient, mRNA, in Moderna’s shot, or the longer time intervals between doses – Moderna’s vaccine is given four weeks apart, and Pfizer’s three weeks.

Moderna’s booster shot is half the dose of the original vaccine.

A real-world Qatari study found that Moderna’s shot was 84.5% effective against any infection from 14 days after the second dose, including asymptomatic illness. Pfizer’s was 53.5% effective, the study found. External factors could influence the results, including that Pfizer’s vaccine has typically been given to older people, who tend to produce weaker immune responses.

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Beyond COVID-19 vaccines, mRNA’s pioneers have big plans for using the technology against a range of diseases

A person in a light-blue protective suit and helmet with face mask near laboratory equipment.
Employees in special suits test procedures for manufacturing the messenger RNA (mRNA) COVID-19 vaccine from Pfizer-BioNTech, in Marburg, Germany.

  • Drugmakers big and small are storming into messenger RNA research.
  • The technology behind the first COVID-19 vaccines could help fight other diseases, including cancer.
  • Early leaders in the mRNA space include Moderna, BioNTech, Pfizer, Sanofi, and GlaxoSmitKline.
  • This article is part of a series called “Future of Healthcare,” which explores how technology is driving innovation in the development of healthcare.

While the COVID-19 pandemic will be remembered as a scourge on humanity, there are silver linings.

Perhaps the biggest success story has been coronavirus vaccines, which were developed in record time and have undoubtedly saved millions of lives. Looking beyond the pandemic, the underlying technology behind the leading COVID-19 shots could also be useful for many other diseases, potentially leading to dozens of new treatments and vaccines over time.

The first vaccines, developed by Pfizer-BioNTech and Moderna, are based on a new technology platform called messenger RNA, or mRNA. While drug companies have been working on mRNA-based medicines for years, the COVID-19 vaccines are the first mRNA vaccines to be authorized and widely used.

Now, scientists are eager to usher in a new era of medicine, applying the learnings from COVID-19 to a range of illnesses, including cancer, HIV, and rare diseases.

Only a few years ago, mRNA was seen as a promising but unproven idea in drug development. Now, the world’s largest drugmakers – like Pfizer, GlaxoSmithKline, and Sanofi – are building their mRNA capabilities as the pandemic has vaulted relatively smaller biotechs like Moderna and BioNTech to record valuations.

mRNA taps into genetic insights over the past decades

Many vaccines aim to deliver a crucial protein to cells to teach them to fight off a certain pathogen. The mRNA approach uses genetics to go a step back in that process.

Our cells convert DNA to RNA molecules. RNA tells cells how to produce proteins. mRNA vaccines deliver those genetic instructions to build a certain protein, rather than the protein itself.

Drug engineers can design mRNA therapies to control which protein to make and how much. That mRNA sequence is then placed in a microscopic blob of fat, called a lipid nanoparticle, which carries the genetic payload into our cells.

Because mRNA therapies can theoretically be designed in the lab, mRNA holds the promise of addressing a wide range of diseases. Moderna CEO Stephane Bancel often calls it “plug-and-play” technology, where scientists can design additional mRNA sequences with a higher-than-usual chance they’ll work.

The mRNA pipeline extends beyond COVID-19

The mRNA technology won’t be limited to vaccines.

Moderna is already testing in human studies potential vaccines against the flu, cytomegalovirus, respiratory syncytial virus, and Zika. Vaccines against the mononucleosis-causing Epstein-Barr virus, the Nipah virus, and HIV are still in the earliest stages of research. The Massachusetts biotech is also developing mRNA treatments for the Chikungunya virus and is exploring research into auto-immune disorders and cancer.

The German biotech BioNTech originally focused on fighting cancer with mRNA. That’s still reflected in its pipeline, where the bulk of the research is in oncology. The biotech is in the early stages of human studies testing its mRNA technology against a range of cancer types, including melanoma, prostate cancer, breast cancer, and ovarian cancer among others.

BioNTech also has some additional vaccine research. In partnership with Pfizer, it’s working on a flu vaccine that has yet to start human testing. BioNTech also partnered with the University of Pennsylvania in 2018 to work on vaccines for infectious diseases.

Capturing the attention of drug giants

Moderna and BioNTech are far from alone.

While Pfizer partnered with BioNTech to develop the COVID-19 vaccine, the pharma giant is hiring its own mRNA team that will work independently from BioNTech. Pfizer has mapped out three waves of mRNA research: more infectious-disease vaccines, expanding to rare disease and cancer, and potentially going into prevalent heart and inflammatory diseases if there’s more evidence the approach will work.

Meanwhile, in August, the French pharmaceutical company Sanofi said it would buy Translate Bio, a tiny Massachusetts biotech specializing in mRNA, for $3.2 billion. CEO Paul Hudson said the deal will allow Sanofi to work on mRNA in vaccines, immunology, oncology, and rare diseases.

GlaxoSmithKline has also invested in its own mRNA program, which is led by its Rockville, Maryland vaccine research unit. The British pharma company hasn’t specified its long-term plans in mRNA, but started an early stage human study testing its own potential mRNA COVID-19 vaccine earlier this year. The leader of its vaccine unit has pledged GSK will be a leader in mRNA and also has inked a partnership with CureVac, a German mRNA specialist, to develop a next-generation COVID-19 vaccine.

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Fauci says it’s likely only Pfizer vaccine will be used at outset of booster campaign

Dr. Anthony Fauci on "Face the Nation"
Dr. Anthony Fauci said the Pfizer booster shot would like have approval by September 20.

  • Dr. Anthony Fauci said the Pfizer vaccine would likely be approved for use as a booster by September 20.
  • But approval for the Moderna vaccine will likely come after, creating a snag in the White House booster rollout.
  • “We’ve said right from the very beginning, we’re not going to do anything unless it gets the appropriate FDA regulatory approval,” Fauci said.
  • See more stories on Insider’s business page.

Dr. Anthony Fauci, the longtime director of the National Institute of Allergy and Infectious Diseases, said Sunday that the Pfizer COVID-19 would likely be the only vaccine used at the outset of the US booster shot effort starting later this month.

The Biden administration in August announced its plan to begin the rollout of COVID-19 booster shots to fully vaccinated individuals on September 20. The current plan is to offer boosters eight months after individuals received their last shot, as Insider previously reported. In the US about 52% of people are fully vaccinated, according to Johns Hopkins University.

Initially, officials said they hoped that both the Moderna and Pfizer vaccines would be approved by the US Food and Drug Administration for booster shots by September 20, while research about a booster shot for those who received the single-shot Johnson & Johnson vaccine continued.

“We were hoping that we would get both the candidates – both products – Moderna and Pfizer rolled out by the week of the 20th. It is conceivable that we will only have one of them out, but the other will likely follow soon thereafter,” Fauci said Sunday on CBS News’ “Face the Nation.”

But Fauci said it was likely the Pfizer vaccine, but not the Moderna vaccine, would gain authorization for the booster shots through the US Food and Drug Administration by September 20, the White House’s target date.

“We’ve said right from the very beginning, we’re not going to do anything unless it gets the appropriate FDA regulatory approval and then the recommendation from the Advisory Committee on Immunization Practices,” Fauci said.

He said it looked like Pfizer had their data in time to meet the deadline.

“We hope that Moderna would also be able to do it so we could do it simultaneously, but if not, we’ll do it sequentially. So the bottom line is very likely, at least part of the plan will be implemented, but ultimately the entire plan will be.”

The push for booster shots comes as the US last week closed in on 39 million confirmed coronavirus infections since the start of the outbreak last year, or almost 12% of the population.

Also Sunday, Fauci said studies were ongoing about whether an individual who received the Moderna or Johnson & Johnson vaccines would be able to mix-and-match and receive a Pfizer booster instead. For now, he said those who received a Pfizer shot should receive a Pfizer booster, and individuals who received the Moderna shots should wait for the Moderna booster to become available.

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Fully vaccinated people are almost twice as likely to have no symptoms than unvaccinated people if they catch COVID-19, a study suggests

volunteer vaccine COVID
A volunteer hands out vaccination information at a pop-up vaccination center in Halifax, England on July 31, 2021.

  • Fully vaccinated people who caught COVID-19 were twice as likely to get no symptoms, a study found.
  • But most vaccinated people in the study didn’t catch COVID-19.
  • Study authors said vaccinated people who interacted with vulnerable people should get regular tests.
  • See more stories on Insider’s business page.

Fully vaccinated people that catch COVID-19 are almost twice as likely to get no symptoms than those who haven’t had a vaccine, a large UK study suggests.

The study from researchers at King’s College London was published in The Lancet Infectious Diseases medical journal late Wednesday. It found that fewer than 0.2% of 971,504 fully vaccinated adults studied caught COVID-19 at least a week after their second dose.

But, for the 2,370 who did get infected post-vaccination, the likelihood of having no symptoms increased by 94% compared to someone who’s unvaccinated, the study authors said.

The scientists also found that the likelihood of catching COVID-19 with five or more symptoms in the first week of illness was reduced by about a third in those fully vaccinated. The likelihood of getting hospitalized with COVID-19 after two doses of a COVID-19 shot was reduced by two-thirds, they said.

The study authors said that the findings highlighted the importance of regularly testing vaccinated people regardless of symptoms. This was especially the case if they interacted with unvaccinated people or those vulnerable to COVID-19, such as those who are older or with underlying health conditions.

Dr. Claire Steves, co-lead study author, said in a statement that the findings “highlight the crucial role vaccines play in larger efforts to prevent COVID-19 infections, which should still include other personal protective measures such as mask-wearing, frequent testing, and social distancing.”

Read more: Experts explain why the mRNA tech that revolutionized COVID-19 vaccines could be the answer to incurable diseases, heart attacks, and even snake bites: ‘The possibilities are endless’

The research, which was funded by the UK government, used the Zoe app, a symptom-tracker with more than 4.7 million users worldwide.

The researchers compared those who said they were vaccinated with either Pfizer, Moderna, or AstraZeneca’s vaccines and those who were unvaccinated. They took into account other factors like age, health risk factors and geographical location that may impact the results.

The symptoms they looked at included: fever, chills, persistent cough, fatigue, shortness of breath, loss of smell, hoarse voice, chest pain, tummy pain, diarrhoea, confusion, eye discomfort, dizziness, sore throat, unusual muscle aches, blisters on feet, worse hayfever, hair loss, and brain fog.

The self-reported nature of the data means that some data was inaccurate or missing. A COVID-19 infection was proven either with a lab test or quicker lateral flow test.

Protection against variants

The study, which took place between December 8, 2020, and July 4, captured infections caused by both the formerly dominant Alpha variant and the highly infectious Delta variant, which has mutations that help it avoid the immune response. But the variant that the participants caught was not looked at in the study.

Previous real-world studies have shown that Pfizer and AstraZeneca’s vaccines are 88% and 60% effective respectively against COVID-19 with symptoms caused by the Delta variant that’s now most common in most countries worldwide, including the UK and US.

Dr. Sara Oliver, epidemic intelligence service officer at the CDC, said in a presentation on Monday that since Delta appeared, vaccine effectiveness against hospitalization ranged from 75% to 95%.

In the US, 52.4% of people are fully vaccinated, while in the UK, 64% of Brits are fully vaccinated, according to the Johns Hopkins University.

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Black particles found in Moderna vaccine vial in Japan, forcing region to put shots from the batch on hold

moderna vaccine
A container of the Moderna COVID-19 vaccine is seen at the United Memorial Medical Center on December 21, 2020 in Houston, Texas.

  • Black particles were reportedly discovered in a COVID-19 Moderna vaccine vial in Japan.
  • As a result, Kanagawa prefecture has paused administering a batch of the rest of the shots, BBC and Reuters reported.
  • The incident comes after Japan another batch of 1.63 million doses were pulled last week.
  • See more stories on Insider’s business page.

Black particles were discovered in a COVID-19 Moderna vaccine vial in Japan, prompting a region to pause administering a batch of the shots, reports said.

A pharmacist in Kanagawa prefecture found several black particles in the vaccine vial on Tuesday while it was being checked out for foreign substances before use, the BBC and Reuters reported.

About 3,790 people already received vaccine jabs from the same batch before the rest of it was put on hold, the reports said.

The incident is being investigated by the vaccine’s domestic distributor, Takeda Pharmaceutical, which collected the apparently contaminated vial.

There was no immediate evidence of health hazards caused by the potentially contaminated vaccine, the BBC reported, citing local reports.

Takeda Pharmaceutical and Moderna did not immediately return requests for comment by Insider on Wednesday.

The incident comes after Japan suspended the use of about 1.63 million doses last week after reports of “foreign substances” were found in vials. Japan’s health minister said on Tuesday that a batch in Okinawa was contaminated after needles were incorrectly inserted into the vials, according to the BBC.

The possible contamination could have been caused by a manufacturing issue at Moderna’s manufacturing site in Madrid operated by Rovi, the company previously said.

Meanwhile, Japan’s health ministry said Wednesday that the potentially contaminated vaccine vial in Kanagawa was from a different batch than the others. The health ministry added that rubber stopper material seems to have made its way into it amid the manufacturing process, Reuters reported.

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Vaccines could get authorized for young kids this fall. Here are the drug companies’ most likely timelines.

children covid-19 vaccine
Monserat Ramos, 3, kept a close eye on the needle as her grandparents got vaccinated in Los Angeles on March 5.

  • Coronavirus vaccines won’t be available for children under 12 until fall at the earliest.
  • Pfizer expects to know how its vaccine performs among kids ages 5 to 11 by the end of September.
  • Moderna could produce data for that same age group in late fall or early winter.
  • See more stories on Insider’s business page.

It’s one of the US’s biggest hurdles to getting the population vaccinated: Children under 12 – nearly 15% of the country, or around 48 million Americans – aren’t yet eligible to receive coronavirus shots.

Both Pfizer and Moderna entered young kids into their clinical trials in March, but the results of those studies haven’t been published.

Pfizer expects to have data about its vaccine’s efficacy among kids ages 5 to 11 by the end of September. It usually takes the Food and Drug Administration a few weeks to review such data, so that would put the US on track to start administering shots to young kids in October at the earliest, assuming the trial results are good.

Data for the other age group Pfizer is studying, children ages 6 months to 5 years, could be available shortly thereafter, Pfizer said in July. The company previously estimated that results for its youngest age group could be available by October or November.

Moderna, meanwhile, expects to have data about its vaccine’s efficacy among young kids in late fall or early winter.

Federal health authorities and Wall Street analysts have offered slightly different timelines

Fauci
White House Chief Medical Advisor Anthony Fauci.

Former FDA Commissioner Scott Gottlieb, who sits on Pfizer’s board, told CNBC on Monday that the FDA could greenlight Pfizer’s shot for kids under 12 in late fall or early winter.

But he added that Pfizer’s emergency-use application “probably isn’t going to be submitted until some point in October.” From there, he estimated, the FDA might take four to six weeks to review the data.

White House Chief Medical Advisor Anthony Fauci told NBC’s “TODAY” last week that “there’s a reasonable chance” that younger kids could be vaccinated by the winter holidays.

But Wall Street analysts have a slightly more optimistic timeline.

In a Tuesday report, Morgan Stanley analysts said they expected Pfizer to submit an emergency authorization for kids ages 5 to 11 in September, putting the US on track to vaccinate this age group in the fall. The analysts estimated that Pfizer would produce data for kids ages 6 months and up in November, meaning the youngest kids could get vaccinated in late 2021 or early 2022.

Moderna, they said, could produce data for kids ages 6 to 12 in the fall, around one to two months after Pfizer. Data for kids 6 months and up would then be available in late 2021 or early 2022, they added, meaning Pfizer could file for emergency authorization for its youngest age group next year.

The FDA hasn’t yet authorized Moderna’s and J&J’s shots for older kids

kid pfizer vaccine
Malikai McPherson, 16, received Pfizer’s vaccine at a clinic in Melbourne, Florida, on May 17.

The FDA asked both Pfizer and Moderna to expand their under-12 trials in July, citing concerns that the studies weren’t large enough to detect rare side effects such as heart inflammation.

Until then, Pfizer had been studying its vaccine in up to 4,500 young children, divided among two age groups: 5 years to 11 years and 6 months to 5 years. Moderna’s trial, meanwhile, included three age groups – 6 years to 11 years, 2 years to 5 years, and 6 months to less than 2 years – each with 2,265 participants. The FDA asked both companies to include at least 3,000 children in the 5-to-11 age group, The New York Times reported.

The FDA authorized Pfizer’s shot for children ages 12 to 15 in May. But Moderna is still waiting on the agency to authorize its shot for kids from 12 to 17, after seeking emergency authorization in June. The FDA could greenlight that shot for this age group any day now.

Johnson & Johnson is on a slower timeline. The company won’t start studying its vaccine among children ages 12 to 17 until this fall. If the shot is shown to be safe and effective among older kids, J&J could then start enrolling 2- to 11-year-olds, followed by children younger than 2.

That means a single-dose shot likely won’t be available to kids until sometime in 2022.

Young children may receive a lower dose

israel kid vaccine
A boy received the Pfizer vaccine in the Israeli city of Holon, near Tel Aviv, on June 21.

Pfizer’s phase-one trial indicated that a lower dose of its vaccine – 10 micrograms, as opposed to the 30 given to adults – is safe among children ages 5 to 11. The trial administered an even smaller dosage, 3 micrograms, to children ages 6 months to 5 years, who seemed to tolerate it well.

Moderna is similarly comparing its standard dose (100 micrograms) with lower doses for all age groups. Children ages 2 to 12 in the trial are receiving either 50 or 100 micrograms, and kids between 6 months and 2 years are receiving either 25, 50, or 100.

A lower dose could help avoid unnecessary side effects. Adolescents in Pfizer’s trials seemed to develop side effects more frequently than adults, likely because kids’ immune systems rev up quickly. But even the most common side effects, such as fatigue and headaches, were relatively minor.

Since the FDA has fully approved Pfizer’s vaccine for people 16 and older, pediatricians can legally prescribe the shot for “off-label” use in young kids. But health officials have warned them not to do so yet.

“Keep in mind kids are not just scaled down adults,” Francis Collins, director of the National Institutes of Health, said on “Good Morning America” last week. “They have different immune systems and metabolism. You really have to do the careful trials to make sure you got the dose right and there aren’t any surprises.”

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Fauci says US still planning for COVID-19 booster after 8 months. Biden said shots could be administered after 5.

Anthony Fauci appears on Meet the Press
Dr. Anthony Fauci said Sunday that the mRNA vaccines were going to require a third dose.

Dr. Anthony Fauci, the longtime director of the National Institute of Allergy and Infectious Diseases, said Sunday that the US was still planning to administer booster shots of the COVID-19 vaccine eight months after the last dose.

“We’re still planning on eight months,” he said during an appearance on NBC’s “Meet the Press.” This rollout will start on the week of September 20.

“That’s the plan that we have, but we are open to data as they come in,” he added. The booster shots will have to be first authorized by the Food and Drug Administration and the Advisory Committee on Immunization Practices, which advises the Centers for Disease Control, he said.

During a meeting at the White House on Friday with Israeli Prime Minister Naftali Bennett, Biden said US health officials were considering following Israel’s lead in administering booster shots as soon as 5 months. Israeli officials on Sunday opened up booster shot to all people who have already been fully vaccinated against the disease, as the Israeli Times reported.

“We’re considering the advice you’ve given that we should start earlier,” Biden said last week, according to CNBC. “Should it be as little as five months, and that’s being discussed.”

But Fauci, the chief medical advisor to Biden, said Sunday the plan had not changed.

“Right now, we’re sticking with eight but we’re totally open to any variation in that based on the data,” Fauci said.

Discussions around booster shots come as cases of the coronavirus are again surging in the US.

Also Sunday, Fauci said he agreed that it was likely the Pfizer and Moderna mRNA vaccines always required a third dose while the Johnson & Johnson vaccine required a second, despite officials earlier this year recommending just two doses of the mRNA vaccines and just one of the Johnson & Johnson vaccine.

“We were dealing, Chuck, with a total emergency situation,” he said. “If we had the grace to be able to do this in a very slow, measured manner, the Phase 2 study would have given various intervals of dosing. It is entirely conceivable that when all is said and done the standard regime will be a three-dose shot for the mRNA and a two-dose shot for J&J.”

“But if you go back to when we were doing this, we were really fighting against time,” he added. “We were having to save lives and we needed to do it very quickly. So, I don’t think there was anything errant or wrong in the way we started it with two doses, but at least now we’re being very open and flexible that we may need that third dose.”

He said he was “certain” the mRNA vaccines would require a third dose.

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