Signs are beginning to appear publicly indicating that scientists responsible for bureaucratic decision-making on drug policy are frustrated by the way the White House has handled the proponents of the coronavirus vaccine.
Why it’s important: The Biden administration has made it clear that its priority, as far as drivers are concerned, is to stay ahead of the virus. But in doing so, progress is also being made in the process by which these decisions are normally made.
Leading the news: Two people responsible for the FDA vaccine are stepping down this fall, the agency announced yesterday.
- Officials are leaving, at least in part, because they feel the FDA is on the sidelines, Endpoints reported, and “what he finally did for them was get the White House to get ahead of the FDA. in reinforcement shots “.
- On Monday, an independent CDC advisory committee hinted it would only initially recommended booster shots for older Americans and health care workers: a subtle exit from the administration’s plan to offer a booster shot to most Americans eight months after their first round.
- And at least one committee member raised concerns on the fact that the White House is ahead of the FDA and the CDC in terms of enforcement policy, reported Helen Branswell of STAT.
What they say: “It’s really awkward because we have to plan like we do it even before we have the data. And of course, scientists think it’s not the right way to do it, but there’s no other way to do it. . do it, ”a senior administration official told Axios.
- “That doesn’t mean we act if the data doesn’t support it, but we do have to plan,” the official added. “It’s uncomfortable for scientists. They don’t like it. But they don’t have to plan how to vaccinate 200 million people.”
What we are seeing: The administration has said time and time again that its plan to start offering boosters on Sept. 20 is subject to FDA and CDC approval.
- Their commitment to this promise may end up being tested in the coming weeks if government scientists disagree with the plan.
The big picture: The CDC recently released data that, like other research, found that the effectiveness of coronavirus vaccines against infection has decreased over time. On the other hand, CDC data also found that the effectiveness of vaccines against serious diseases has been maintained.
- Data on the effectiveness of boosters are still leaking from other countries or from the pharmaceutical companies themselves, and Pfizer said this week that there may be no additional data on the need for boosters until late September or early September. of October.
- Whether booster shots are necessary or justifiable, given the apparent longevity of protection against serious disease and the global shortage of vaccines, is a matter of debate among experts.
“These are our data as well as international data that has led us to worry that the decline we are seeing from infection will soon lead to the decline we would see from hospitalization, serious illness and death, which is why it is so important now to plan “Stay Ahead of the virus, “CDC director Rochelle Walensky told reporters yesterday.
Editor’s note: This story has been corrected to show that Pfizer said there may be no additional data on the need for reinforcements until September or October (no initial data).