FDA aims to give final approval for Pfizer vaccine by early next month – World Latest News Headlines

He said different recommendations on boosters for different vaccines could confuse the public. Fully approving a vaccine and then authorizing boosters for it too soon could send conflicting messages about its effectiveness.

While research is ongoing, senior administration officials believe that at least vulnerable populations such as those with compromised immune systems and older people will need them, according to people familiar with their thinking. But when to administer them, which vaccines to use and who to give the pill are still being discussed.

In A study posted online last weekScientists at Pfizer and BioNTech reported that the effectiveness of Pfizer’s vaccine against symptomatic disease fell from about 96 percent to about 84 percent four to six months after the second shot, but continues to provide strong protection against hospitalization and serious illness. Is. kept.

Administration officials said Moderna and Johnson & Johnson also needed to submit the data and asked Moderna to do so quickly. Officials have said other studies will also influence their decision-making, with the government collecting data on the rate of success infection among thousands of people, including health care workers.

Pfizer is expected to submit an application for a booster shot to the FDA this month. While the FDA can authorize such shots, the Centers for Disease Control and Prevention will need to recommend them after a meeting of an external committee of experts.

Pfizer’s decision to fully approve the vaccine would give doctors more leeway to prescribe additional shots for at least some Americans, including those with weakened immune systems. The CDC was exploring possible special programs for that group, but administration officials said it had become clear that by the time such initiatives were launched, the Pfizer vaccine would already be fully approved. and Dr. Can write shots.

According to the CDC, about 3 percent of Americans — or about 10 million people, by some estimates — have compromised immune systems as a result of cancer, organ transplants or other medical conditions, while studies indicate that vaccines prevent them. While some work well, others do not produce the immune response that would protect them from the virus.

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