Friday, December 3rd, 2021

Biden administration to have boosters available

Despite a plan by the Biden administration to have boosters available to nearly all Americans by late September, the FDA had only authorized a third shot of the Pfizer-BioNTech vaccine for certain populations, such as those 65 and older and people with underlying medical conditions, up until this point.

With enough convincing evidence to demonstrate safety in those groups, experts said they were frustrated that it took until now to authorize the Pfizer-BioNTech and Moderna boosters for everyone else.

Friday’s authorization by federal officials to expand Covid-19 booster shot eligibility to all adults was met with overwhelming support from public health experts. But some were puzzled as to why the Food and Drug Administration didn’t make the move sooner.

“This is too late,” said Dr. Robert Murphy, executive director of the Institute for Global Health at the Northwestern University Feinberg School of Medicine and a professor of infectious diseases. “What is the problem in getting the best treatment out there quickly?”

The FDA signoff, which was followed by an endorsement from the Centers for Disease Control and Prevention, formalizes what has cropped up in a patchwork of states in recent days. Governors from Massachusetts to California have allowed people 18 and older to get boosters. Their decisions come ahead of the holidays, when indoor gatherings are expected to lead to a spike in Covid cases, including breakthrough infections.

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“We’ve had the evidence for the need for boosters for several months,” said Dr. Dorry Segev, professor of surgery at Johns Hopkins University School of Medicine and professor of epidemiology at Johns Hopkins Bloomberg School of Public Health.

He added that he has heard of people fibbing to get boosters before they officially qualify.

“When you have people exaggerating their work situation or their medical risk situation or feeling like they have to flat-out lie to get the protection they need, that’s a failing on the FDA and CDC’s part,” he said.

But others were not as quick to cast judgment, arguing the FDA needed time to review safety data, including the rare risk of myocarditis associated with the Covid shot and a third dose of it.

If anything, said Dr. Gregory Poland, director of the Mayo Clinic’s vaccine research group, the FDA was “working at record speed,” given that Moderna only submitted its application for booster expansion earlier this week and Pfizer did so earlier this month.

“I think it would have been a public relations disaster to say ‘We aren’t going to review the data, we’re just going to approve it,’” he said.

Tener Goodwin Veenema, a professor and visiting scholar at the Johns Hopkins Center for Health Security, agreed.

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“I just don’t think there’s anything to be gained in looking backwards and criticizing what has happened. We are still in the midst of a pandemic. We are looking at the potential of another surge,” she said. “We just have to keep a laser-focus on getting as many Americans vaccinated as possible, including children who are now age-eligible.”

The FDA did not respond to NBC News regarding its booster shot timeline. In an interview Friday with The Associated Press, the agency’s vaccine chief, Dr. Peter Marks, said “we move as rapidly as we can.”

“We have to do the right analyses to make sure that when we take an action, we can stand behind it,” he said. “Our goal is to make sure that the person who is on the fence, or perhaps doubting whether to take the vaccine, feels confident enough in our decisions that they are willing to come along and take the vaccine or take the booster.”


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