Despite all 19 members of the Vaccine and Related Biological Products Advisory Committee voting “yes” after the lengthy presentation, many members still had concerns over the data they saw from Moderna and the Israel Health Ministry.
The committee will hold a similar hearing Friday to review data on the Johnson & Johson booster dose.
The decision is seen as crucial for both companies and Biden administration’s vaccine rollout program, but scientific data, as ever in politics, is only one part of the story and can be read in a number of ways. Studies so far suggest that mixing and matching boosters will work at least as well and could be far better for single-shot J&J recipients - but the FDA panel remains split on the decision.
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Many members disagreed with this notion, saying booster shots were unnecessary in healthy young people.
“I worry about this broad use of boosters,” Dr. Paul Offit said. He said he is impressed with continued protection from the first two doses and fears a push for a booster shot will “send the wrong message” to people that they are not protected without three doses.
“The people who are in the ICU aren’t there because they haven’t gotten a third dose,” Offit said. “They are there because they haven’t gotten any dose.”
Dr. Michael Kurilla said younger people seem to be responding well to the first two doses and he doesn’t see a need to start a campaign for boosters for everyone who has ever been vaccinated.
But Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, said the committee has to think ahead as COVID-19 variants continue to spread.
“We don’t know what we don’t know,” he said.
Marks said winter could be worse, bringing another variant of concern.
“We can’t look at the current pandemic curve and call it a day,” he added.
The hearing Thursday was riddled with technical glitches and audio issues.
Friday, the committee will decide if “available data supports the safety and effectiveness of Janssen COVID-19 vaccine for use under EUA [emergency use authorization] as a booster dose in individuals 18 years and older at least two months after a single dose primary vaccination.”
If yes, they will decide if “available data supports that an interval of at least six months between a single primary dose and a booster dose may result in a more robust booster response.”
If no, they will decide if “available data supports the safety and effectiveness of Janseen COVID-19 vaccine for use under EUA as a booster dose in individuals 18 years and older at least six months after a single dose primary vaccination.”
The booster would be administered six months after the completion of the primary series for:
Individuals 65 years of age or older Individuals 18 to 64 years of age at high risk of severe COVID-19 Individuals 18 to 64 years of age who are put at a higher risk of severe COVID-19 due to their occupation
The committee will decide on Johnson & Johnson’s booster dose Friday.
With the committee’s recommendation, the FDA will make its final decision on whether to approve the vaccine. Then, the Centers for Disease Control and Prevention (CDC) will meet to discuss their recommendation for the vaccines. After that, the CDC Director has the final signoff.
The CDC’s Advisory Committee on Immunization Practices is already set to meet to discuss boosters on October 20 and 21.
He said “it is clear” he has “real issues with this vote” and said he voted yes based on “gut feeling” rather than “truly serious data.”
Many committee members expressed concerns about the data presented by Moderna and Israeli health officials when discussing the voting question.
Such concerns included the half doses of the Moderna booster, the relevance of the data from Israel for the American population and the risk for people at a greater risk of contracting COVID-19 because of their occupation.
It was a unanimous 19-0 vote to back Moderna’s third dose.
Califf served as the FDA’s deputy commissioner for medical products and tobacco from February 2016 to February 2017.
While Califf is a contender, a final decision has yet to be made.
“There has not been a decision made for the FDA commissioner and we remain grateful to the strong acting leadership at the FDA,” a White House official told CNN Thursday.
Dr. Janet Wodcock has served as the acting FDA commissioner for the past nine months. She cannot legally stay on as the acting head of the FDA past November 15 unless a permanent commissioner has been nominated.
In order to promote global vaccine equity, Miller said Moderna will open localized manufacturing facilities in Africa and send 1 billion doses to low-income countries.
She also added that the reduced 50 mg dosage of the Moderna COVID-19 booster shot will “make more vaccines available for the world.”
When asked about the timeline for the manufacturing facilities, Miller could not provide any further information.
The committee will meet on November 30 to discuss the available data on the use of the oral drug in adults who have tested positive for COVID-19 and are at high risk of hospitalization or death.
“We believe that, in this instance, a public discussion of these data with the agency’s advisory committee will help ensure clear understanding of the scientific data and information that the FDA is evaluating to make a decision about whether to authorize this treatment for emergency use,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
He said those decisions “will be made based on science.”
“These boosters are free, available and convenient to get,” he said.
He added that the FDA will also decide on approving vaccines for children aged 5 to 11.
“We have purchased enough vaccine for children between the ages of 5 and 11 in the United States,” he said, adding that if the vaccine is authorized, “we are ready.”
“We have a lot more to do,” he said.
Biden did mention the decrease in COVID-19 cases and hospitalizations and said roughly 34 million Americans have gotten vaccinated since July.
However, he said there is an “unacceptably high” number of Americans who are still unvaccinated.
He ended his brief remarks asking those who are still unvaccinated to get their shot.
“We are headed in the right direction,” he said, “but we can’t let up now.”
Ron Milo, a professor at Israel’s Weitzman Institute, said their data suggest that COVID-19 cases in Israel would have continued to rise exponentially without the booster shots.
“There is no question in my mind now that the break in the curve was due to the booster dose,” Dr. Sharon Alroy-Preiss, the director of public health services at the Israel Ministry of Health, said.
Data from Modera showed that pain at the injection site is the most common solicited local reaction, while headache, fatigue and myalgia are the most common systematic reactions.
Axillary swelling or tenderness were the only adverse reactions that were more frequently reported after booster compared to the first two doses, Miller said.
She added that all reports of the adverse reactions were mild to moderate in severity.
While the 50 mg booster is a lower dose than the first two shots in the primary series, Miller said this will help “increase worldwide vaccine supply.”
The committee will vote on whether the available data support the safety and effectiveness of the Moderna COVID-19 vaccine as a booster dose at least six months after the first series is complete in three distinct populations.
Individuals 65 years of age and older Individuals 18 to 64 years of age at high risk of severe COVID-19 Individuals 18 to 64 years of age whose frequent exposure to COVID-19 because of their jobs outs them at a high risk of serious complications of COVID-19, including severe COVID-19
This is similar to the request from Pfizer authorized by the FDA last month.
The “booster does adverse events are not more acute than the first or second dose,” according to the data summary.
Officials are looking into the causality of reported cases of myocarditis after receiving the booster shot, but Israel Ministry of Health’s Dr. Sharon Alroy-Preis said the rate of myocarditis is low compared to what was seen after the second dose.
Out of 2.5 million booster doses in Israel, there were 17 cases of myocarditis or perimyocarditis, data found.
She added that cases were reported three to five days after the second dose, while this study tested for myocarditis months after the third dose, which may be the reason for the low rates reported after the booster.
Results show a sharp decrease in severe infections among vaccinated people - and later among the unvaccinated as well as the benefits of the extra dose move through the population.
Dr. Peter Marks told the group that the effectiveness of Pfizer-BioNTech’s drug against catching the virus reduces over several months time - but that protection against hospitalization remains high.
They also pointed towards poor testing regimes in many countries.
Moeti called on wealthy countries once again to send large shipments of vaccine to the continent “now rather than next year”.
Around 40,000 people on average are being infected each day in the country and hospital admissions are on the rise once again, prompting concerns from officials that the health service is already struggling to cope.
Speaking at a press conference, he said the future of Japan is at stake in the upcoming lower house election on October 31, as he seeks a mandate to lead the country and continue his plan to deal with COVID-19 just weeks after becoming PM on October 4.
Osbourne’s family, on the other hand, hasn’t been so lucky. His wife Sharon Osbourne was hospitalized with Covid in December last year, and one of his daughters also contracted the virus.
The judge, in Kern County, issued a temporary order that prevents enforcement of the vaccine mandate for unionized guards that was due to take effect tomorrow. But the mandate will still apply to other workers at prisons that have healthcare facilities.
The rule is aimed at preventing another COVID outbreak like one that killed 28 inmates and a correctional officer at San Quentin State Prison last year, lawmakers say, but the California Correctional Peace Officers Association continues to strongly oppose the measure.
The shaky evaluation leaves the FDA advisory panel split ahead of the discussions - but the group will ultimately need to come to an agreement in the coming days. If it does recommend a booster for J&J, the agency will also need to decide whether recipients should get the shot two months or six months after initial vaccination.
FULL STORY: FDA Split on When or if J&J Vaccine Recipients Need Booster
The airline told employees last week that they would be required to get the vaccine by December 8 - leaving less than two months to enforce the requirement. Mass flight cancellations earlier this week sparked false claims from some social media users and politicians, including Texas Senator Ted Cruz, that pilots and air traffic controllers had either walked off their jobs or called in sick to protest the mandate.
FULL STORY: Southwest Doesn’t Know How Many Pilots Unvaccinated Against COVID, Union President Says
“So, I’m being escorted out of UCLA for standing up for medical freedom, despite coming to work, willing to work,” Vafaeenia says in the video.
The executive appeared on CNN’s ‘Connect’ show last night to talk about the plans.
Common side effects from all vaccines include a sore arm, a low-grade fever, and other mild flu-like symptoms lasting only a few days.
FULL STORY: Fauci Warns Vaccine-Hesitant Pilots: Getting COVID Should Be Greater Concern
Follow Newsweek’s liveblog throughout Thursday for all the latest.
