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FDA to get Israeli 3rd vax data

Israel remains far ahead of the rest of the world in its proactive vaccination drive against the coronavirus.

By Erin Viner

At least 2.6 million people out of a population of 9.3 million have already received 3 doses of the Pfizer/BioNTech SE vaccine in Israel.

While seniors have been administered the third shot since July, Israel also began offering the jab last week to individuals as young as 12.

Israeli health officials believe the effectiveness of the second dose of the Pfizer vaccine waned 5 months after administration, making a booster necessary. A third dose restores the level of protection of the second shot, they say; adding that the campaign has succeeded in diminishing severe illness caused by the Delta variant.

The Head of Public Health at the Health Ministry of Health, Sharon Alroy-Preis, announced that Israel will be presenting its findings on booster shot to advisors at the United States Food and Drug Administration (FDA) during a virtual briefing on 17 September.

“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 told Israeli Channel 12 TV news.

US President Joe Biden had been expected to launch a campaign to administer 100 million booster shots, after health officials in the country said in August that a third shot would be made widely available on 20 September to Americans who either received  doses of either the Pfizer-BioNTech or Moderna vaccines at least 8 months earlier.

US vaccine producers other than Pfizer, however, are lagging in applying for necessary authorization of the additional dose.

Moderna Inc. only finalized submission of data for regulatory approval of the boosters last Friday. The delay caused White House Chief Medical Advisor Dr. Anthony Fauci to voice doubt that the Moderna vaccine would be available in time for the planned rollout. “It may be a delay for a few weeks. We don’t know,” he said during an interview with the MSNBC network on Friday.

Johnson & Johnson, meanwhile, has not yet asked regulators to approve a booster for its one-dose shot. The company has only said that is in discussions with the FDA on the subject.

According to a source familiar with the matter cited by Reuters, White House COVID Coordinator Jeffrey Zientz was informed last Thursday by Acting FDA Commissioner Dr. Janet Woodcock and Director of the Centers for Disease Control and Prevention (CDC) Dr. Rochelle Walensky that their agencies may be able recommend boosters by late September, limited to certain recipients of the Pfizer-BioNTech vaccine.