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Israel said worried FDA limit on booster shots will hamper its 3rd shot campaign

Unfazed by Israeli data on vaccines’ fading effectiveness, FDA panel okays 3rd shot only for those over 65 or high risk; now Israel fears wariness, legal challenges at home

An Israeli woman over 60 receives a third coronavirus vaccine shot at a Clalit health clinic in Jerusalem on August 8, 2021. (Olivier Fitoussi/Flash90)
An Israeli woman over 60 receives a third coronavirus vaccine shot at a Clalit health clinic in Jerusalem on August 8, 2021. (Olivier Fitoussi/Flash90)

Senior Israeli Health Ministry officials expressed concern early Saturday that a US FDA panel decision to initially only recommended COVID vaccination booster shots to those over 65 or at high risk, could undermine Israel’s third shot campaign. Officials said they now fear greater wariness about the 3rd vaccine and potential legal challenges over its mandating a third shot as part of its Green Pass policy.

Discounting Israeli data and expert testimony, the committee of outside experts who advise the Food and Drug Administration on Friday rejected, by a vote of 16-2, boosters for nearly everyone. Members cited a lack of safety data on extra doses and also raised doubts about the value of mass boosters, rather than ones targeted to specific groups.

Then, in an 18-0 vote, it endorsed the extra shot only for select portions of the US population — namely, those most at risk from the virus.

Officially, despite the panel appearing to reject Israeli data presented to the FDA that shows vaccine effectiveness wanes after around six months, the Israeli Health Ministry welcomed the rulings, saying they validated Israel’s decision to offer 3rd shots to all aged 12 and over.

“With the FDA board’s unanimous decision on giving boosters to those above 65 and in danger, and also to health workers — exactly as we began doing here — the FDA has validated the booster program initiated in Israel.”

While Israel started by initiating the booster program for similar at-risk groups, it rapidly expanded eligibility to all those 12 and over.

“Israel has decided to act in a responsible and swift manner in order to tackle rising morbidity and the data points to the high effectiveness of the booster shot that restores the protection against the coronavirus,” the statement said.

President Isaac Herzog and his wife Michal receive their third COVID-19 vaccine shots at Sheba Medical Center, July 30, 2021. (Haim Zach/GPO)

However, a senior ministry official told the Ynet news site that Israel was concerned the ruling would undermine the booster program that has now seen over 3 million Israelis get their third shot.

“I have no doubt that this will affect the percentage of people who will get the third shot; I’m sure that many now will be unsure [that it is necessary],” the official told Ynet.

He also said it could affect Israel’s ability to make its Green Pass, which allows people into public events and communal spaces, conditional on having the third shot.

“Could people who decide not to get the third shot based on FDA recommendations challenge our Green Pass policy?” he asked, anticipating legal challenges to the decision to mandate a third shot, six months after the first two, in order to qualify for the pass.

The FDA panel’s overwhelming rejection came despite full-throated arguments about the need for boosters from both Pfizer and health officials from Israel, which began offering boosters to its citizens in July. Israeli officials presented figures to the FDA panel indicating waning immunity against infection among all age groups around six months after vaccination.

Sharon Alroy-Preis, head of public health at Israel’s Ministry of Health, told the FDA panel the booster dose improves antibody protection tenfold against infection in people 60 and older.

“It’s like a fresh vaccine,” bringing protection back to original levels and helping Israel “dampen severe cases in the fourth wave,” she said.

Israeli Health Ministry official Dr. Sharon Alroy-Preis and Prof. Ron Milo of the Weizmann Institute address a FDA panel that is weighing whether to approve booster shots of the Pfizer-BioNTech vaccine in the United States, September 17, 2021. (Screen capture: YouTube)

Both Pfizer and the Israeli representatives faced pushback from panelists. Several expressed skepticism about the relevance of Israel’s experience to the US. Another concern was whether third doses would exacerbate serious side effects.

The twin votes also represented a heavy blow to the Biden administration’s sweeping effort to shore up nearly all Americans’ protection amid the spread of the highly contagious delta variant.

The over 65 decision would help salvage part of the White House’s campaign but would still be a huge step back from the huge plan proposed by the administration a month ago to offer booster shots of both the Pfizer and Moderna vaccines to nearly all Americans eight months after they get their second dose.

Friday’s vote was just the first step. The FDA itself is expected to make a decision on boosters in the next few days, though it usually follows the committee’s recommendations.

Used vials of the Pfizer-BioNTech COVID-19 vaccine lay empty at a vaccination center at the University of Nevada in Las Vegas, January 22, 2021. (AP Photo/John Locher, File)

The offering of boosters is also subject to approval by the Centers for Disease Control and Prevention. A CDC advisory panel is expected to take up the question on Wednesday. The CDC has said it is considering boosters for older people, nursing home residents and front-line health care workers, rather than all adults.

Separate FDA and CDC decisions will be needed in order for people who received the Moderna or J&J shots to get boosters.

During several hours of vigorous debate Friday, members of the panel questioned the value of offering boosters to nearly everyone.

Scientists inside and outside the government have been divided in recent days over the need for boosters and who should get them, and the World Health Organization has strongly objected to rich nations giving a third round of shots when poor countries don’t have enough vaccines for their first.

While research suggests immunity levels in those who have been vaccinated wane over time and boosters can reverse that, the Pfizer vaccine is still highly protective against severe illness and death, even amid the spread of the highly contagious delta variant.

However, representatives for Pfizer argued that it is important to shore up immunity before protection against severe disease starts to erode. A company study of 44,000 people showed effectiveness against symptomatic COVID-19 was 96% two months after the second dose, but had dropped to 84% by around six months.

Panel member Dr. Cody Meissner of Tufts University said he is worried about extra doses for younger age groups given the risk of heart inflammation that has been seen in mostly younger men after a second dose. While the condition is very rare, he said, it is not clear if that risk would increase with another dose.

Pfizer pointed to Israeli data from nearly 3 million boosters to suggest side effect rates would be similar to that seen after second doses.

An Israeli teenager receives the COVID-19 vaccine at a vaccination center of the Tel Aviv municipality and Magen David Adom, in Tel Aviv on July 4, 2021. (Tomer Neuberg/Flash90)

Biden’s top health advisers, including the heads of the FDA and CDC, first announced plans for widespread booster shots a month ago, targeting the week of September 20 as an all-but-certain start date. But that was before FDA staff scientists had completed their own assessments of the data.

Earlier this week, two top FDA vaccine reviewers joined a group of international scientists in publishing an editorial rejecting the need for boosters in healthy people. The scientists said continuing studies show the shots are working well despite the delta variant.

The US has already approved Pfizer and Moderna boosters for certain people with weakened immune systems, such as cancer patients and transplant recipients.

Some Americans, healthy or not, have managed to get boosters, in some cases simply by showing up and asking for a shot. And some health systems already are offering extra doses to high-risk people.

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