A panel of expert outside advisers to the US Food and Drug Administration who Friday overwhelmingly rejected a proposal to administer a third vaccine shot to all people over the age of 16, voted unanimously to administer the booster to people 65 and older and those at high risk of illness.
“The US Food and Drug Administration (FDA) tonight unanimously recommended giving a booster dose to people over the age of 65 and people at risk, as well as to health care workers – just as we did first,” the Israeli Health Ministry said in a statement.
“In doing so, the FDA validated the third vaccination campaign, which began in Israel and subsequently in Canada, Austria, Germany, France and other countries.”
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The news came shortly after the Israeli Health Ministry announced 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.
“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.”
He said that “those who are vaccinated are protected.”
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
He said that “those who are vaccinated are protected.”
Finally, Prime Minister Naftali Bennett laid out the next goal: “Four million vaccinated,” he tweeted. “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
Third vaccine doses being administered at the Amigdor Retirement Residence by Magen David Adom (MDA), Jerusalem, August 5, 2021. (credit: MARC ISRAEL SELLEM)
The panel voted overwhelmingly against approving boosters for Americans age 16 and older, potentially undermining the Biden administration’s plan to roll out third shots of the Pfizer/BioNTech vaccine as soon as next week.
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
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. Most of them said they would support boosters for older Americans, but did not think they were needed yet for younger adults.
Dr. Sharon Alroy-Preis, the director of Public Health Services in Israel, presented data from Israeli studies to the advisers early Friday.
Her presentation was based on two different sets of data, one that showed 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 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 original “fresh” vaccine efficacy that was reported against the original Wuhan strain.
“In Israel, it was decided to act responsibly and quickly in order to treat the growing morbidity, as evidenced by the high efficacy data of the booster dose, which protects against the coronavirus,” the Health Ministry said in a statement.
Top FDA members have 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.
If the FDA goes ahead and approves the booster, a separate panel advising the U.S. Centers for Disease Control and Prevention (CDC) will meet next week to recommend which groups should get them.
The White House said it was ready to roll out boosters next week if health officials approve the plan.
In total, more than 6 million Israelis have already been vaccinated with at least one shot, including more than 5.5 million who have received both doses.
The Health Ministry reported on Friday that 3,227 people were diagnosed with coronavirus the day before – 6.33% of the roughly 55,000 people who screened.
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