WASHINGTON – This is the week President Joe Biden signaled to launch a massive coronavirus recall campaign that would ultimately reach all vaccinated people across the country. Instead, the recall effort is mired in criticism and confusion at home and abroad.
Food and Drug Administration advisers have decided to recommend booster shots only for people over 65 or at special risk – rather than Biden’s public preference for all 16 and over – after a month of controversy in which top FDA scientists resigned and outside medical experts complained that the White House appeared to be pressuring the agency to green light boosters for all.
Once again, Biden took heat for an artificial deadline, as medical experts questioned the decision to put a public calendar on the widespread availability of booster shots.
“I think that would have been one thing to say, look, logistically, operationally, the big retail pharmacy chains, the health services, the hospital system have to be ready to give reminders – but for it to be release to the general public ‘the recalls are coming Sept. 20, it’s a very different thing, “said Dr Celine Gounder, an infectious disease expert who advised Biden’s transition.” I think that’s where it is. this communication went wrong. “
Biden and his senior public health officials made the highly unusual decision to announce last month, ahead of the FDA’s standard review process, that those 16 and over would start receiving booster shots this week. But a panel of FDA advisers rejected the plan on Friday, voting that the boosters should only be given to the elderly and those at increased risk of infection.
Biden announced the plan and schedule in a televised address, but White House officials have sought to distance him from the effort in recent days, stressing that the decision was made by his senior health officials, including the acting commissioner of the FDA and the director of the Centers for Disaster Control and Prevention.
When the administration announced it, officials said the plan hinged on approval from the FDA and a panel of CDC advisers who will intervene this week. Surgeon General Dr Vivek Murthy said on Friday the administration would follow the recommendations of the FDA and CDC.
“We have always said that this initial plan would depend on independent evaluation by the FDA and CDC,” he said. “We will follow this assessment and their recommendations. We will ensure that our final plan reflects this.”
Yet over a million people have already received third doses, which have been allowed to be given as boosters only to people with immune system disorders; the numbers rose sharply after officials announced their stimulus package.
White House Covid coordinator Jeffrey Zients said the administration has decided to present its own plan to the FDA to be transparent about its thinking about boosters and to give healthcare providers time to prepare.
While the White House has accepted the criticism, some public health officials have defended the approach, saying officials need to get out quickly to prepare the public for the likelihood of recalls, especially as other countries have acted. and that the number of revolutionary cases in the United States has increased.
“I think the White House did the right thing by foreshadowing that recalls would be needed,” said Dr Leana Wen, emergency physician and former Baltimore health commissioner. “What if they hadn’t said anything? Even then, Israel, the UK, Germany, among others, were already talking about boosters. There was a growing chorus of experts asking what would be their plan for boosters. “
Biden is expected to come under pressure at the United Nations General Assembly meeting in New York this week from world leaders who pleaded with the United States to do more to help the billions of people who have yet to received their first doses of a vaccine before providing people in the United States with third shots.
The World Health Organization has called for a “moratorium” on recalls, and other international medical groups have lambasted Biden for pushing for third doses in the United States when only 20% of those eligible in the Low-income countries have been at least partially vaccinated, up from around 80 percent in some of the wealthier countries, according to the WHO.
“I will not remain silent when the companies and countries that control the global vaccine supply think the world’s poor should be content with leftovers,” WHO Director-General Tedros Adhanom Ghebreyesus said during a press conference this month. “Because manufacturers have prioritized or have been legally compelled to enter into bilateral deals with rich countries willing to pay top dollar, low-income countries have been deprived of the tools to protect their populations. “
Biden, who has indicated he will announce new U.S. efforts to help with global sourcing this week, plans to ask world leaders at a Covid virtual summit on Wednesday to pledge to improve equitable access to vaccines, oxygen supplies, testing and protective equipment; and building a better health financing system.
Responding to criticism, White House officials said the United States was able to both give boosters and lead efforts to vaccinate the world, citing the 140 million doses it has already delivered to more than 90 countries. The United States plans to ship at least 200 million more doses this year.
Administration officials declined to comment on a Washington Post report on Friday that the White House was in talks with Pfizer to purchase millions of additional doses of its vaccine to donate overseas.
Meanwhile, COVAX, an international organization tasked with ramping up vaccine production and distribution, said this month it expects to fall short of its target of delivering 2 billion doses to developing countries. This year. Instead, the group said it expects to have access to 1.4 billion doses this year, unless producers and high-income countries prioritize sending vaccines to people. low income countries.
“It makes us look very bad, not that it should dictate our decision-making on this issue, but it doesn’t look good,” said Gounder, the infectious disease expert. “I’m just not impressed with how we’ve stepped up our efforts to try to get the rest of the world vaccinated. I don’t think the efforts have been enough.”
CORRECTION (September 19, 2021, 5:45 p.m. ET): An earlier version of this article misrepresented when the Director General of the World Health Organization criticized U.S. recall plans. He made the remarks on September 8, not last week. He also misstated when a group of CDC advisers were due to meet to discuss the booster injections. The meeting is scheduled for this week, not next week.