�������ýҕ�l

Pfizer says it plans to meet with top U.S. health officials Monday to discuss the drugmaker’s request for federal authorization of a third dose of its COVID-19 vaccine as President Joe Biden’s chief medical adviser acknowledged that “it is entirely conceivable, maybe likely” that booster shots will be needed. The company said it was scheduled to have the meeting with the Food and Drug Administration and other officials Monday, days after Pfizer asserted that booster shots would be needed within 12 months. (Yen, 7/11)

Pfizer is expected to brief top U.S. government health officials in the coming days about the need for a coronavirus vaccine booster shot after an unusually public spat between the pharmaceutical giant and federal officials over whether a third shot will be necessary, according to the company and six people familiar with the plans. Pfizer and the German firm BioNTech announced on Thursday that they planned to seek regulatory approval for a booster within weeks because they anticipated that people would need a third dose six to 12 months after receiving the companies’ two-shot regimen. (Abutaleb, Pager, McGinley and Sun, 7/10)

Dr. Anthony Fauci told CNN's Wolf Blitzer that Pfizer CEO Albert Bourla apologized to him for not giving health officials advance notice that the company would seek an authorization for a third dose of its coronavirus vaccine. After Pfizer's announcement, the Centers for Disease Control and Prevention and the Food and Drug Administration published a joint statement saying Americans do not need boosters yet. (Doherty, 7/10)

Anthony Fauci said on Sunday that the FDA giving Covid vaccines full approval is “only a technical issue” and that the hundreds of millions of people across the world who have been vaccinated serve as evidence that “the effectiveness and the safety of the vaccines are very high.” As of July 4, about 157 million Americans were fully vaccinated, almost half of the population. Many people are hesitant or have decided to wait to be vaccinated until the vaccines shift from being labeled “emergency use authorization” to “fully approved.” Speaking on ABC’s “This Week,” President Joe Biden's top medical adviser told host George Stephanopoulos, “There are certainly some people who when you use the terminology ‘emergency use authorization,’ they kind of think it's a tenuous data showing that it works so that it's safe. That's not the case.” (Greene, 7/11)

The Food and Drug Administration issuing full approval for two Covid-19 vaccines might not be the game-changer it’s chalked up to be, according to a number of leading public health experts. Increasingly, some leading academics and physicians have pushed back on the popular narrative that the FDA is needlessly delaying full approvals for the Pfizer and Moderna coronavirus shots — and spurring vaccine hesitancy by doing so. While full approvals might encourage a handful of Americans to finally get vaccinated, they argue, it’s more important for the agency to make clear that the eventual approvals are motivated by science and not by public pressure. (Facher, 7/12)