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Pfizer-BioNTech seek U.S. OK for second COVID booster for 65 and older -Breaking

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© Reuters. FILE PHOTO A healthcare worker in Los Angeles prepares the Pfizer coronavirus (COVID-19), vaccination, on January 7, 2021. REUTERS/Lucy Nicholson/File photo

(Reuters] -Pfizer, Inc. and BioNTech Se (NASDAQ:) filed a request with U.S regulators Tuesday for an emergency use authorization to give a second shot of the COVID-19 vaccine to people 65 or older.

Data from Israel were used in the submission to U.S. Food and Drug Administration. A second booster has been authorized for many over-age people.

Companies said that an analysis of more than a million older adults revealed lower rates for confirmed illnesses and severe disease among people who were given an extra booster dose at four months. This was in comparison to individuals who only received one dose.

The news was first reported by the Washington Post https://wapo.st/3i7nJwO earlier on Tuesday.

U.S. officials, including Dr. Anthony Fauci, a top expert in infectious diseases have often raised the prospect of a fourth shot. This suggests that one may be required for seniors and prepares for another spike of cases.

U.S. Centers for Disease Control and Prevention data have shown that vaccine efficacy decreases with time and that third shots are effective in restoring that efficacy. But, it does not release comprehensive data based on health status or age.

Pfizer (NYSE:) Albert Bourla, Chief Executive of the Company, has stated several times to reporters in the last week that the fourth shot will be required to compensate for the loss of protection from the first shot.

According to him, data shows that a fourth dose significantly improves the protection of Omicron virus variant dominant Omicron. This is a comparison with the third dose which was given after six months.

Israel had previously published mixed data.

Based on data from the health ministry, Israel said that a fourth shot doubled infection protection and provided greater protection against severe diseases than those who received three.

This analysis is more positive than the small study done by Israeli health workers. If given within four months of the last shot, the fourth dose of the Pfizer BioNTech vaccine was 30 percent effective for infection prevention and the 11% for treatment. Moderna (NASDAQ:) Inc vaccine.

Dan Barouch from Harvard, who is a vaccine researcher, said that the elderly and the immunocompromised would be the best beneficiaries of an additional boost. Although the evidence is strong, the benefit seems to be modest.

Pfizer has begun to study how a fourth dose does in its own 600-person research. Moderna and Pfizer are betting that additional booster doses may be required for any new viruses.

COVIDs are declining in America and other parts of the globe, but Omicron-related infections are increasing in China. The downward trend in COVID incidences has been reversed in Europe as well as the UK. This is due to the opening of economies and the introduction of Omicron 2.

Pfizer said last month that 2022 sales of the COVID-19 vaccine might not exceed its forecast of $32 Billion, which is a 13% decrease from 2021.

According to a Washington Post report, the FDA intends to meet with its advisory group in April. They will discuss the possibility of an October-November campaign, to promote boosters for adults, as well as whether shots should remain the same or modified to fight newer variants.

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