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Growing fears that the swift-moving delta variant of the coronavirus could ignite a firestorm of serious illness – resulting in a further spike in hospitalizations and deaths – prompted a forthcoming announcement by the Biden administration to recommend booster shots for the millions of Americans who have been vaccinated, officials said.
Data from an array of sources – including the Centers for Disease Control and Prevention, the Mayo Clinic and Israel – shows immunity from the vaccines declines over time and suggests that greater protection may be needed to fight off the highly contagious mutated strain, according to several senior officials who spoke on the condition of anonymity to discuss internal deliberations.
The administration is expected to outline the plan Wednesday during a White House covid-19 briefing, in which health officials are poised to tell Americans they should get a booster shot eight months after being inoculated. President Joe Biden is expected to speak on the effort after the briefing, White House press secretary Jen Psaki said Tuesday.
The news about the administration’s plan drew praise and criticism. Supporters welcomed the move, citing the worrisome turn in the pandemic. Critics said the United States should not give out extra doses until more of the global population gets a first round of shots. Others complained the decision to recommend boosters, even tentatively, could interfere with the standard Food and Drug Administration process for weighing extra doses.
But officials involved in high-level discussions in recent days said they had little choice but to act with urgency. They said they had been tracking data for months showing declines in vaccine protection, calculating when people would need boosters and estimating how long it would take to distribute the shots. The Washington Post’s seven-day average of daily U.S. coronavirus cases stood at more than 139,000 Tuesday – four times higher than a month earlier.
“You are talking about the mass vaccination of hundreds of millions of people,” one official said. “You can’t just wait until you have all the information and then make a plan. You have to make a plan ahead of time and give a fairly good lead time.”
The eight-month timetable being announced Wednesday applies only to the Pfizer and Moderna shots, developed with a similar technology. Officials will say they expect individuals who received the Johnson & Johnson vaccine to need a booster shot, but the timetable for those shots is subject to a review of data still coming in.
The officials said Tuesday that the plan being announced Wednesday is conditional on FDA approval of extra shots. Currently, the agency does not have enough data from vaccine manufacturers to make a final decision but expects to receive more information in coming weeks from Pfizer-BioNTech, Moderna and Johnson & Johnson.
“You announce the plan with a lot of caveats,” one official said.
The FDA last week authorized a third dose of the Pfizer-BioNTech and Moderna vaccines for people with fragile immune systems, including patients taking immunosuppressive drugs because of organ transplants or those receiving cancer treatment.
If the FDA clears the boosters in the next several weeks, the extra shots would begin to be rolled out in mid-to-late September, officials said. Given the eight-month time frame, those who received shots first when the nation’s vaccination drive started – health-care workers and residents in long-term care facilities in late 2020 and early 2021 – are likely to be first in line for additional doses.
Administration officials conceded that some Americans are likely to seek out booster shots before eight months elapsed and that there could be a surge in the early months of the booster effort, but said they are confident they have enough vaccine doses to meet the demand.
In recent months, administration officials have kept a close eye on Israel’s experience with the Pfizer-BioNTech vaccine. Recently, the Israeli government released data showing that for people 65 years and older who were inoculated in January, the vaccine was less than 55% effective against severe disease and hospitalization. The decline in effectiveness, which has been showing up in Israeli data for several weeks, has prompted that nation to begin administering booster shots to people age 50 and above.
Some experts said they found the Israeli data confusing. But asked about the effect of the Israeli information on U.S. decision-making, a federal official said: “It’s very relevant and potentially important. … Other data are tending to corroborate what they are seeing, so we have to take it seriously.”
Officials are also scrutinizing data released last week from the Mayo Clinic, which found that the effectiveness of the Pfizer vaccine in preventing infections had fallen to 42 percent in July. Still, the vaccine remained highly effective against severe cases that could result in hospitalization.
Early data on the ability of booster shots to beef up immunity appears encouraging. On Monday, Pfizer and BioNTech submitted early-stage clinical trial data to the FDA as part of their application for a booster shot for people who received the original two-shot series. The companies said in a news release that the additional dose generated “significantly higher neutralizing antibodies” against the delta variant and earlier strains.
The data suggests a third dose of the vaccine “elicits antibody levels that significantly exceed” those measured after the two-dose regimen, Albert Bourla, Pfizer’s chief executive, said in a statement.
Some experts say the government’s effort to approve boosters could be partly overtaken by events. By the end of the summer, the FDA is expected to give the Pfizer vaccine – not the booster – full approval. Currently, the vaccine is distributed under an emergency use authorization. When the vaccine gets full approval, doctors are permitted by law to use the product however they want, as long as the use is considered reasonable.
Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine and co-director of the Center for Vaccine Development at Texas Children’s Hospital, said the need for boosters is in some ways predictable. He said the emergency authorizations were done in a way “to get people vaccinated as quickly as possible,” with the two-shot regimens of the Pfizer-BioNTech and Moderna vaccines spaced three to four weeks apart. He said that worked to get people immunized fast, but not to build long-lasting immunity.
“We knew there was a trade-off for using that immunization schedule and ultimately we would have to boost,” Hotez said. “It was just a question of when.”
While Hotez said the recommendation for boosters “makes sense,” the policy, logistics and regulatory process “seems very messy.” Typically, the FDA would approve boosters as safe and effective and then the CDC and its advisers would recommend who should get them and when.
The question of boosters became increasingly fraught as the pandemic unfolded, with the ferocity of the delta variant surprising scientists. Data continues to accumulate suggesting that vaccines lose some anti-virus potency over time, but officials have been reluctant to highlight that fact because they are still trying to persuade broad swaths of Americans to get vaccinated – which is considered the best way to exit the pandemic. They are also not sure how much of the reduction in protection is from the passage of time and how much is attributable to the variant.
The decision to recommend boosters marks a dramatic shift from public statements by top officials in recent months. In July, the CDC and FDA said in a statement, “Americans who have been fully vaccinated do not need a booster shot at this time.” Officials have repeatedly said it was not clear whether boosters would be needed.
But as cases started to rise again and more breakthrough cases were reported, the tone from administration officials started to change. Last week, Anthony S. Fauci, the White House chief medical adviser, said it was “likely” everyone will need a coronavirus booster at some point.
At the same time, the World Health Organization has criticized more-affluent nations for moving ahead with plans to provide boosters. The WHO has called for a halt to booster shots at least through September, saying it would be better – more ethical and more effective in taming the pandemic in the long run – to use the shots to inoculate people overseas.
“I will tell you that we believe that it – that is a false choice,” Psaki said Tuesday. “We can do both, and the United States is far and away the biggest contributor to the global fight against covid. We will continue to be the arsenal for vaccines around the world. We also have enough supply and we have long planned for enough supply should a booster be needed for the eligible population.”
Krishna Udayakumar, director of the Duke Global Health Innovation Center, has pressed the White House for months about global inequity in vaccine distribution. But Udayakumar said he is cautiously optimistic that administering a third shot to some Americans won’t detract from delivering first shots to much of the developing world.
“If we can follow the science and undertake boosters in high-risk populations at the right time, it can be done in a way that doesn’t significantly alter the availability of vaccines to the rest of the world,” Udayakumar said. “We’re at a point where in the next one to two months, we are likely to see manufacturing capacity of something close to a billion vaccines a month.”
But Udayakumar stressed that the U.S. booster strategy needed to be married to more commitments abroad.
“It puts more pressure on the White House and President Biden to make sure that the rhetoric around being a ‘global arsenal of vaccines’ is actually more than rhetoric,” he said. “If we are to make this announcement soon, I would hope that it’s coupled to an announcement of the additional steps we’re going to take to lead the global recovery and response,” such as a pledge to hold a global coronavirus summit or additional, targeted commitments for vaccine distribution.
Other experts said the delta variant had changed the global calculus.
Eric Topol, director of the Scripps Research Translational Institute, said that while he is sensitive to global inequity, the United States is facing its own crisis, given that the nation is driving a significant share of the international outbreak.
“We don’t have our house in order at all,” Topol said. “As the third-largest country, we’re generating a huge burden of covid, and with that comes the potential for nurturing functional variants.”
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