Israel Pushing FDA to Approve Booster Shots For Americans; Fauci Says 3rd Jab Likely Coming Sep 20

Israeli health officials have agreed to present data from their country's rollout of Covid-19 vaccine booster shots to the FDA, potentially providing ammunition to help the Biden administration justify such a program in the US.

The US Food and Drug Administration (FDA) asked Israel's Health Ministry to brief the agency's advisory committee on booster-shot data at the panel's September 17 [virtual] meeting, according to Sharon Alroy-Preis, the ministry's head of public health.

"We have been asked to come and present Israel's experience and our data so that we can truly help the whole world to learn," Alroy-Preis said on Sunday in an interview with the country's Channel 12 TV.

Israel launched its booster-shot program on August 1, citing the waning efficacy of Covid-19 vaccines over time, and has so far administered the additional jabs to about 2.6 million people, or roughly 28% of the population.

After saying booster shots will likely be needed for people to be considered ‘fully vaccinated' against Covid, White House health adviser Dr. Anthony Fauci said Pfizer could have approval for a further dose in a matter of weeks.

During an appearance on CBS' Face the Nation, Fauci revealed the Pfizer-BioNTech shot will likely be the only approved booster dose given authorization by September 20, the date the Biden administration previously said it wants to see booster shot distribution begin.

Moderna's vaccine will meanwhile need more time to get "appropriate approval," Fauci said. He did not give a timeframe for the Johnson & Johnson vaccine, though they have been working on a booster shot, as well.

"We were hoping that we would get the, 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 would likely follow soon thereafter," Fauci said.

Pfizer will likely meet the deadline because they have "their data in" in time to get approval from the Food and Drug Administration (FDA) and the Advisory Committee on Immunization Practices.

Health officials with the Biden administration announced last month that booster shots would be required eight months after a Moderna or Pfizer second dose. Officials have cited more spreadable coronavirus variants such as Delta for the reason for needing further doses.

Fauci's comments follow him saying that once booster shots are available, a third dose will "likely" be required for people to be considered "fully vaccinated." With only Pfizer ready to get approval, however, it might leave many people who were once considered vaccinated now in need of another dose and likely subsequent proof if they plan on going to an event or business requiring inoculation.

On Tuesday, two top FDA vaccine regulators resigned — a decision that one former official said was rooted in anger over the agency's lack of autonomy in the booster planning so far. A current health official said the pair, Marion Gruber and Philip Krause, left over differences with FDA's top vaccine official Peter Marks. Now the agency is facing a potential mutiny among its staff and outside vaccine advisers, several of whom feel cut out of key decisions and who view the plan to offer boosters to all adults as premature and unnecessary.

[...] much of the discord within the agency centers on the administration's decision to push ahead with boosters before FDA's top scientists had a chance to weigh in.

[...] Biden added to the confusion and controversy last weekend when he suggested that boosters could be administered just five months after the initial regimen, rather than the eight his administration had just proposed. Those remarks, coming after a meeting with Israeli Prime Minister Naftali Bennett, fueled worries that an administration that had pledged to "follow the science" was letting politics dictate outcomes.

Pfizer expects revenue from the COVID-19 vaccine will reach $33.5 billion this year — a 29% jump from the previously estimated $26 billion. https://t.co/K6WyUYpRrk

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