Biden team to roll out vaccine booster plan ‘very shortly’

The Biden administration will announce a plan “very shortly” to give booster shots to people who completed their initial round of COVID-19 vaccination eight months ago, a top federal official said Monday.

The U.S. is expected to administer third shots of the Pfizer-BioNTech and Moderna vaccines by mid-September as it tries to fend off the fast-moving delta variant of the coronavirus.

“We have been meeting and discussing about this almost daily, and we will have something to announce very shortly about boosters because we do believe the time has come to have a plan for Americans,” National Institutes of Health Director Francis Collins told radio host Hugh Hewitt. “It’s a combination of delta being a particularly nasty variant that’s very contagious, and the fact that unsurprisingly, vaccine protection does gradually wane over time.”

The Food and Drug Administration would need to approve the third shot of the Pfizer and Moderna vaccines, which use a messenger RNA platform that instructs the body to mount an immune defense. Recipients of the one-shot Johnson & Johnson vaccine will likely need boosters but the decision will depend on the results of a two-dose trial.

Some scientists say they would like to see more data on the need for boosters.

“It’s unclear to me that there is a need for booster vaccination for the general population because we’re not seeing fully vaccinated individuals be hospitalized to a great degree,” said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security.

“This is the threshold I use. It could be the case that the administration wants to be proactive with getting boosters ready and they have already purchased vaccines for boosters. However, the clinical benefit is unclear to me.”

Dr. Collins said the move toward boosters is based in part on data from Israel, which got a quick start on vaccination and is tracking outcomes closely. People who were immunized in January are the ones who are starting to see breakthrough infections, and while many cases are not serious there are signs of symptoms and hospitalizations.

“That’s the same thing we’re starting to see in the U.S. data, although right now, it’s still as if our vaccine protection is working really well. But we don’t want to wait until it’s like oh, too late,” Dr. Collins said.

The booster rollout is expected to mirror the original deployment of the vaccines. For instance, health care workers and then older populations would receive the first wave of third doses because they are furthest from their initial course, with some of them receiving their first shot last December.

“If you start boosting with the people who got their vaccines earliest, you’re going to end up vaccinating particularly the nursing homes, the health care providers, the elderly, because they’re the ones who got doses first,” Dr. Collins said. “So it kind of all fits together.”

Dr. Collins defended the stepwise approach, saying it makes sense to wait at least six months before thinking about a booster so the immune system has a chance “to mature the diversity of antibodies that it can produce.”

“So if somebody just got their primary immunization, you know, a couple of months ago, I don’t think this is the right moment for that booster,” he said.

Last week, the federal government approved a booster shot for a small portion of the population that is immunocompromised including solid organ transplant recipients and those with other conditions that weaken their immune systems. Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, estimates that immunocompromised individuals who might need a booster shot make up less than 3% of adults.

Public health officials in San Francisco announced earlier this month that people who received the single-shot Johnson & Johnson coronavirus vaccine can get an extra “supplemental” dose of the Pfizer or Moderna vaccine although the FDA has not approved the move.

Israel has been administering boosters to older adults while other countries including Germany, Russia and Britain have greenlighted the extra shots for some people.

The U.S. has the supply to offer the extra doses to people in a “fast and efficient way if and when the science dictates,” Jeff Zients, the White House COVID-19 response coordinator, said at last week’s pandemic briefing.

On the regulatory side, Pfizer and BioNTech said on Monday that they submitted data to the FDA for approval for a booster dose of their vaccine. They said a booster dose given within six to 12 months after the initial vaccination round might help maintain strong protection against COVID-19 due to “high levels of immune responses observed.”

“Vaccination is our most effective means of preventing COVID-19 infection – especially severe disease and hospitalization – and its profound impact on protecting lives is indisputable. Still, with the continuing threat of the delta variant and possible emergence of other variants in the future, we must remain vigilant against this highly contagious virus,” Pfizer CEO Albert Bourla said. “The data we’ve seen to date suggests a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule.”

Moderna in May said that data from its phase two study showed that a booster dose of its vaccine showed increased antibody responses against the original coronavirus strain and variants first identified in South Africa and the United Kingdom.

Dr. Collins said it would be best for booster recipients to obtain the same version of the vaccine they received initially so the collected data on immune responses is consistent.

It is possible to mix and match vaccines but more data is needed to know how effective that is, according to Dr. Adalja.

“There is some suggestion that it may be more effective because different technologies might stimulate different parts of the immune system and we have done that in experiments with bird flu vaccines,” he said.

The World Health Organization has criticized wealthier nations for pushing booster plans before the rest of the globe gets its first chance at vaccination.

“Our recommendation remains to make sure that those who are most are risk — older populations, those with underlying conditions and, critically, our health workers — in all countries around the world receive that first, second dose before we do the boosters for those who don’t necessarily need them,” Maria Van Kerkhove, the COVID-19 technical lead for the WHO, told CNN.

Dr. Collins said the U.S. has committed millions of doses to other countries and can walk and chew gum at the same time.

“We’re doing a lot there. You know, 110 million doses already sent out by the U.S., 500 million promised. We are going to have to do our part to deal with the rest of the world’s needs,” he said. “And I don’t think we should try to make this as maybe WHO did as a choice between whether or not we’re going to protect our own people or the rest of the world. We’ve got to do both.”

Dr. Adalja said as a general matter, “third shots are much less important than first shots when it comes to the trajectory of the pandemic in the world and in the United States.”