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Pfizer/BioNTech submit data for COVID-19 booster shots

Booster shots are expected to be approved quickly in the US, as cases of delta variant surge

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COVID-19 booster shots are on the minds of Americans following predictions that the country could soon see 200,000 infections a day, a rate not seen since the height of the pandemic earlier this year.

The warning was given by Francis Collins, director of the National Institutes for Health, who said data from Israel suggesting that vaccine protection was waning among older people should make heath leader rethink their position on booster shots.

Booster shots have been approved in Israel where COVID infection rates have now reached 650 per million, one of the highest levels in the world, despite nearly 80% of people over 12 being vaccinated. More than half of the new cases are in fully vaccinated people, underscoring the danger of the highly contagious delta variant.

The FDA has already given approval for a booster shot among a small group of immunocompromised people; however, Pfizer/BioNTech have announced that they have submitted initial data to the FDA with the aim of expanding their use.

Reports from the Biden White House suggest that a third dose of the vaccine will soon be recommended.

Speaking on US television, Collins said: “The people who got immunised in January are the ones that are now having more breakthrough cases. Mostly, of course, these are symptomatic, but not serious, but you’re starting to see a little bit of a trend toward some of those requiring hospitalisation.”

He said a combination of the rise of the delta variant and a concern that vaccine protection may start to wane will prompt the need for boosters, beginning with healthcare providers, people in nursing homes, then “gradually moving forward” with other groups, such as older Americans who were among the first to get vaccinations.

Pfizer and BioNTech’s submission to the FDA focuses on phase 1 data from their phase 1/2/3 trial on booster shots which shows “a favourable safety profile and robust immune responses”, said the companies. Given the high levels of immune responses observed, a booster dose given within 6 to 12 months after the primary vaccination schedule may help maintain a high level of protection against COVID-19.

“The data we’ve seen to date suggests a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule,” said Pfizer chairman and chief executive officer, Albert Bourla.

Participants in the Pfizer/BioNTech trial received a 30-µg booster dose of Comirnaty (tozinameran, also known as BNT162b2) 8 to 9 months after receiving the second dose, which elicited significantly higher neutralising antibodies compared to the levels observed after the two-dose primary series. The effect was seen against the ‘wild type’ SARS-CoV-2 virus and the Beta and Delta variants of concern.

Pfizer/BioNTech said that phase 3 results would be “expected shortly” and will be submitted to the FDA, the EMA and other regulatory authorities worldwide. In the US, they plan to seek a licence via a supplemental biologics licence application for people 16 years and older, “pending FDA approval of the primary BLA submitted in May 2021”.

Article by
Hugh Gosling

18th August 2021

From: Research, Regulatory

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