• The US FDA releases its briefing document for Pfizer’s application for coronavirus boosters. Source

• Pfizer and BioNTech issue a press release to announce that the US FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend Emergency Use Authorization (EUA) for a third booster dose of their coronavirus vaccine (given at least six months after the initial two doses) for people ages 65 and over and those at high risk of severe COVID-19; in addition, the panel recommended that healthcare workers and others at high risk for occupational exposure should be included in the EUA. The FDA’s decision on booster approval is expected in the coming days.

Although Pfizer and BioNTech applied for a third booster dose for everyone who received the initial two doses, the panel did not approve booster doses for the full population. The companies have submitted the same data to the European Medicines Agency (EMA) and will be filing it with other regulatory authorities in the coming weeks. Source

• Italy will require all of its 18 million public and private sector workers to have a COVID passport, called a Green Pass (which indicates vaccination, recovery from COVID-19, or a negative test result) , as of 15 October. Noncompliance will cost workers up to 1,500 euros; employers who fail to check whether their workers have a Green Pass face fines of up to 1,000 euros. Source

• As South Africa endures its third wave of coronavirus, its National Institute for Communicable Diseases recommends that the nation consider expanding eligibility for coronavirus vaccines to include adolescents ages 15- 18, among whom HIV is highly prevalent – and the most common underlying cause of death from COVID-19. Source

• The Biden administration is negotiating with Pfizer on the purchase of 500 million doses of its coronavirus vaccine, which it plans to donate to other countries. Source

• The US CDC publishes data on the effectiveness of coronavirus vaccines from J & J, Moderna and Pfizer/BioNTech among 3,689 adults (1,682 of them with COVID-19) hospitalized from 11 March until 15 August, 2021; 64 percent were unvaccinated. Overall, mRNA vaccines were more effective; Moderna’s vaccine was 93 percent effective for preventing hospitalization, the Pfizer/BioNTech vaccine was 88 percent effective, and the J & J vaccine was 71 percent effective. Notably, the effectiveness of Pfizer’s vaccine dropped significantly over time, from 91 percent at 14–120 days post-vaccination 77% at >120 days post-vaccination, while efficacy of the Moderna vaccine remained stable. Source

• India’s health ministry reported that the country administered a record-breaking total of 25 million vaccines on Prime Minister Narenda Modi’s 71st birthday. The country plans to reach a billion doses by mid-October. Source

• The UK government announces an easing of some restrictions on international travel in and out of England as of 4 October. Source

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