A panel of expert outside advisers to the US Food and Drug Administration on Friday night overwhelmingly rejected a proposal to administer a third Pfizer vaccine shot to all people over the age of 16, similar to what is being done in Israel.
At the same time, the panel unanimously agreed that a Pfizer coronavirus vaccine booster could be given to people 65 and over, healthcare workers and others at high risk for contracting the virus, such as teachers. The recommendation would cover most Americans who got their shots in the earliest stages of the US vaccination campaign.
“The FDA validated the third vaccination campaign, which began in Israel and subsequently in Canada, Austria, Germany, France and other countries,” the Israeli Health Ministry said in response Friday night.
However, at least on the surface, the policy seems to go against Israel’s decision to roll out the booster to everyone over the age of 12, including requiring anyone who has not gotten the booster or been vaccinated or recovered within the last six months to be tested before entering anywhere that requires a Green Pass after October 1.
There are several reasons for this, including that the United States is about three months behind Israel, so the vaccine is not yet waning as much in younger people, explained Prof. Eran Segal, a computational biologist from the Weizmann Institute of Science.
“Another difference is that when Israel decided to expand the vaccine to young people, the infection rate was around 1.3, higher than in the United States today,” he tweeted on Saturday night. “There is no doubt that the decision in Israel prevented the closure and saved many lives.”
Segal added that the FDA’s vaccination of health workers will mean that many younger people will get a third shot, which will provide them with additional safety data.
“I estimate that the FDA will gradually approve the extension of the vaccine to other age groups, as has happened in Israel, as the effectiveness of the second vaccine continues to decline even among younger people,” tweeted Prime Minister Naftali Bennett.
Israel also did not roll out the booster shot to everyone at once. It first approved the third dose for immunosuppressed people in mid-July. Then, it voted to offer the shot to people over the age of 50 a month later. It was only on August 29 that It opened up the booster to anyone who had received two doses at least five months prior.
THE FDA decision came shortly after the Israeli Health Ministry announced with great fanfare that more than 3 million citizens had received a third COVID shot.
“As of this hour,” said the Health Ministry at 6:10 p.m. on Friday, “3,008,511 vaccinated Israelis have received the booster. By Saturday night, that number was 3,031,423.
But the numbers are not consistent among the different age groups. So far, only 37% of people between the ages of 16 and 19 have had a third shot, 40% between 20 and 29; 47% between 30 and 39 and 61% between 40 and 49. The older population has taken greater advantage of the booster.
“The Health Ministry calls on everyone who is eligible and has not done so to go out and get vaccinated,” it continued. “The vaccine has been shown to be the most effective means of fighting the coronavirus, and is available to everyone.”
עברנו עכשיו את ה-3 מיליון מחוסנים בחיסון המשלים, אפילו מוקדם יותר מהמועד שהצבנו ליעד הזה. החיסון הוא האמצעי הטוב ביותר לעצור את הדלתא, וכבר רואים בבירור את התוצאות בשטח: מי שמחוסן - מוגן. כבוד לצוותים שלנו שעושים עבודה מדהימה, ולציבור שנוהג באחריות. ממשיכים להתחסן!
— Nitzan Horowitz نيتسان هوروفيتس ניצן הורוביץ (@NitzanHorowitz) September 17, 2021
Bennett also tweeted about the success and laid out the next goal: “Four million vaccinated. Immediately after the holidays, we will implement a program to vaccinate another million Israelis with the third vaccine, through the tightening of the Green Pass, PR and accessibility.”
ל-3 מליון הישראלים הטובים והאחראים שהלכו להתחסן: תודה! בזכותכם כולנו בטוחים ובריאים יותר ובזכותכם המדינה שלנו נשארת פתוחה בחגים, ובכלל. היעד הבא: ארבעה מליון מתחסנים. מיד לאחר החגים ניישם תכנית לחיסון של עוד מיליון ישראלים בחיסון השלישי, באמצעות הידוק התו הירוק, הסברה והנגשה.
— Naftali Bennett בנט (@naftalibennett) September 17, 2021
However, as noted, the FDA panel voted overwhelmingly (16-2) against approving boosters for Americans age 16 and older, taking a “step back” from the Biden administration’s plan to roll out third shots of the Pfizer vaccine as soon as next week, said Dr. Paul Offit, an infectious disease expert at the University of Pennsylvania and a member of the advisory panel.
The FDA will take the panel’s recommendation into consideration in making its decision on the boosters. But it can reject the advice, as it did recently in approving Biogen Inc.’s controversial Alzheimer’s drug. It is expected to make its final decision in the coming days.
Many committee members were critical of the booster plan, arguing that the data presented by Pfizer and the FDA is incomplete and that the request for approval for people as young as 16 years old is too broad.
Dr. Sharon Alroy-Preis, the director of Public Health Services in Israel, offered data from Israeli studies to the FDA advisers in English early Friday to help with their discussion.
Her presentation was based on two different sets of data: one showing that the effectiveness of the Pfizer vaccine waned over time and another that showed a significant increase in the vaccine’s effectiveness with a third shot.
In her presentation, she shared research conducted by a diverse team of Israeli scientists and doctors that had been published in the New England Journal of Medicine late Wednesday showing that taking a third dose of the Pfizer COVID-19 vaccine boosts the immunity of recipients more than tenfold compared to those who received only two doses of the vaccine more than five months prior.
The data also showed that the booster offered 20 times more protection against serious disease and that people who get the booster dose become only 5% as likely as unvaccinated people to get sick. In other words, the vaccine efficacy for individuals who got a third dose of the Pfizer vaccine stands at about 95% – similar to the “fresh” vaccine efficacy that was reported against the original Alpha strain.
HOWEVER, WHEN confronted by the FDA advisers as to whether additional shots beyond the third could be needed, she admitted that it was still too early to tell.
“It is not really clear where this is going,” Alroy-Preis said.
Both Health Ministry Director-General Nachman Ash and coronavirus commissioner Prof. Salman Zarka said last week that Israel was preparing to give a fourth shot.
She later said in an interview with N12 that approving the booster for younger people in Israel was “necessary” and that Israel did not “rush the third vaccination; we are ahead of the world.”
Alroy-Preis added that she did not go to the FDA to convince it to approve the third shot.
“The FDA makes decisions for the United States and we make decisions for us,” she stressed.
Just hours before the FDA committee convened, the Centers for Disease Control and Prevention released a new study of around 3,700 Americans over the age of 18 hospitalized at 21 centers throughout the country between March and August that found that protection from the Pfizer shots declined four months after vaccination.
“Vaccine efficacy for the Pfizer-BioNTech vaccine was 91% at 14-20 days after receipt of the second vaccine dose but declined significantly to 77% at more than 120 days,” the report said.
The study did not find the same decline in the Moderna vaccine, it said possibly due to the higher mRNA content in the Moderna shots or differences in timing between doses – three weeks for Pfizer and four for Moderna.
But research as to whether a booster is needed and who needs a booster has been divided.
An essay published in the peer-reviewed Lancet medical journal on Monday came out in opposition to providing third doses to the general population. The authors said that recent studies show that the vaccine continues to offer strong protection against the virus, including the Delta variant. They recommend holding off in order to give vaccine makers time to modify the vaccine to match specific or new coronavirus variants rather than simply providing an extra dose of the original version.
Top FDA members had been split on the necessity of the boosters, with interim head Janet Woodcock backing them and some of the agency’s top scientists arguing they are not needed yet.
The White House maintains it will be ready to roll out boosters next week to anyone who is eligible.
“Today was an important step forward in providing better protection to Americans from COVID-19,” White House spokesperson Kevin Munoz said. “We stand ready to provide booster shots to eligible Americans once the process concludes at the end of next week.”
CDC advisers are scheduled to meet on September 22 and 23 to discuss further recommendations for who will be eligible for the shots. Recent polls have shown that vaccinated Americans want a booster shot to enhance their immunity.
In total, more than 6 million Israelis have already been vaccinated with at least one shot, including more than 5.5 million people who have received both doses.
The Health Ministry reported Saturday night that 4,863 individuals were diagnosed with coronavirus the day before out of the 89,610 who were tested. Some 717 people were in serious condition, including 195 who were intubated.
Reuters contributed to this report.
.