Pfizer-BioNtech to seek US OK for second COVID booster for 65 and older – report

A health worker prepares the Pfizer coronavirus disease (COVID-19) vaccination in Los Angeles, California, US, January 7, 2021. Reuters/Lucy Nicholson/File photo

March 15 (Reuters) – Pfizer Inc. (PFE.N) and its German partner BioNTech SE (22UAy.DE) will get a second booster shot of their COVID-19 vaccine for people 65 and older as soon as Tuesday Will seek emergency use authorization for The Washington Post reported.

The report, citing three people familiar with the matter, said the submission to the US Food and Drug Administration is expected to include data collected in Israel, where a second booster for many people over the age of 18 years old. is authorized.

Neither the company nor the FDA immediately responded to Reuters requests for comment.

Israel has been giving a fourth shot since early January to people over the age of 60, and from late January to people over 18 who meet criteria such as immunity or risk of infection through their work. read more

US health officials, including top infectious disease expert Dr. Anthony Fauci, have raised the prospect of a fourth shot several times, suggesting that one may be needed for older people and prepare for the prospect of another surge of cases. can.

US Centers for Disease Control and Prevention data has shown that the effectiveness of the vaccine decreases over time and that a third shot helps restore that efficacy, but it has not released comprehensive data based on age or health status. has done.

Pfizer chief executive Albert Boerla told reporters several times last week that a fourth dose of the vaccine would be needed to offset the protection that would be achieved with the third shot.

He told the Washington Post last week that data shows the fourth dose dramatically improves protection against the dominant Omicron version of the virus, compared to the third dose after three to six months.

Data previously released by Israel was mixed.

Israel said in late January that a fourth dose doubled protection against infection and increased protection against serious illness by 3 to 5 times compared to those receiving three shots, based on health ministry data.

This analysis was more favorable than that of a small study of Israeli healthcare workers. When at least four months after the third shot, the fourth dose was 30% effective against infection for the Pfizer-BioNTech vaccine and 11% for the Moderna Inc. (mRNA.o) vaccine.

“The elderly and immunocompromised are the groups that would benefit most from the additional boost,” said Harvard vaccine researcher Dan Barouch. “I think the data is helpful, but the benefits appear relatively small.”

Pfizer is looking at how the fourth dose fared in its study of nearly 600 people. It and Moderna are betting that the new virus variant will require an additional booster dose. read more

While COVID cases are retreating in the United States and much of the world, infections are rising in China as the Omicron version spreads. In the UK and Europe, there has been a reversal in the declining trend of COVID cases as economies open up and Omicron’s second edition circulates.

Pfizer said last month that final 2022 sales of its COVID-19 vaccine may not be above its current forecast of $32 billion, a 13% drop from 2021 levels. read more

Separately, the FDA plans to convene its expert advisory panel in early April to consider whether there should be an October or November campaign to encourage some or all adults to receive additional boosters, and whether The shots must be identical to current vaccines or recreated to counter the new variants, the Washington Post reported, citing a federal official.

Reporting by Mrinalika Roy and Manojna Maddipatla in Bengaluru; Additional reporting by Leroy Leo in Bengaluru; Editing by Amy Caron Daniels and Bill Bercroto

Our Standards: Thomson Reuters Trust Principles.