US studies launch of booster doses of COVID-19 vaccine

(Trends Wide) — It is not yet clear whether booster doses of COVID-19 vaccines will be approved for fully vaccinated people in the United States. But the country’s state and local health departments are moving forward with plans for a possible launch next week.

Last month, US health officials announced plans to offer booster doses of the COVID-19 vaccine beginning the week of September 20, subject to approval by the US Food and Drug Administration. United States (FDA) and the Centers for Disease Control and Prevention (CDC).

Those talks are starting this week, including a key meeting of FDA vaccine advisers this Friday, but the decision is not an easy one, experts have said.

Still, those in charge of managing reinforcements can’t wait for the details to be finalized.

“We don’t want to be caught off guard,” Lori Tremmel Freeman, executive director of the National Association of County and City Health Officials (NACCHO), told Trends Wide on Wednesday.

In addition, he said that local health departments are now planning to be ready after Pfizer’s data from the FDA review, especially since they are already “really overwhelmed” right now with the response to waves of covid-19 cases. , working to vaccinate the unvaccinated and preparing for flu season.

(Trends Wide photo)

The last thing local health officials need right now is more chaos or confusion, but many of their questions about boosters have yet to be answered: “What is the interval for boosters? Is it less than eight months at this time? time? Is it the age limit? Will there be priority groupings? “Freeman said. “We don’t want to appear uncoordinated with the authorities.”

What has to happen before additional booster shots are approved?

The FDA’s Advisory Committee on Vaccines and Related Biologics will meet this Friday to discuss whether data on the Pfizer / BioNTech covid-19 vaccine supports the idea of ​​giving a booster dose to people 16 years of age or older for approximately six months after completing your second dose. And there will be more steps before booster doses are approved for the general public.

“It’s important to note that the role of the FDA is really to say whether we can use this, we can use this product, or we can use this booster. It is the CDC that will decide whether or not they should be used,” said Dr. Anna Durbin, Director. from the Immunization Research Center at the Johns Hopkins School of Public Health to Bloomberg, during a virtual briefing on Wednesday.

“So even if the FDA approves the use of boosters saying they are safe and does what they are supposed to do, the CDC will still have to review and approve the use of boosters to say ‘they are really needed, and for whom they are needed. and they might recommend it for different populations: the elderly, for example, or people in nursing homes, we don’t know, “he said.

US health officials have maintained that they want to get ahead of the virus, but not get ahead of the country’s health agencies.

“No one is going to receive vaccine boosters until the FDA says they are approved, until the CDC advisory committee makes a recommendation. What we want to do is be ready as soon as it arrives,” said the Casa’s chief of staff. Blanca, Ron Klain to Trends Wide’s Dana Bash on “State of the Union” earlier this month.

“We will wait one hundred percent for FDA approval, we will wait for CDC approval,” he said.

Klain said that even if the boosters for both doses do not receive full approval by September 20, the administration would still be ready to distribute them by then.

What would be the distribution of additional doses?

The booster implementation plan is not much like previous vaccination efforts, where pharmacies went to nursing homes to vaccinate residents and stadiums had long lines of people waiting for injections at mass vaccination sites.

“There is still a lot of emphasis on pharmacies continuing to play an important role in vaccine administration, and currently more than 70% of doses are administered to pharmacies,” said NACCHO’s Freeman, but added that in some states, certain Pharmacies and hospitals may not participate in booster programs because they will not have the staff capacity to do so, among other reasons.

In those cases, boosters can be given at other sites, such as doctor’s offices or specific vaccine clinics.

“It could look different from state to state,” Freeman said, but emphasized that “there are no limitations” or restrictions on the supply of vaccines.

Rather, “we have been hearing from local health departments, with no confirmed information coming their way, they are beginning to assess who on the ground will have the ability to make backups, who will remain as a vaccine provider and who will cease to be, to that we have a better understanding of how the community will be served and by whom, “Freeman said. “There is a lot of confusion about this.”

How many people could be eligible for the booster shot?

It is not clear what parameters the US reinforcement program will have, if at all.

The Biden administration previously said that US residents would be eligible for a third dose of the covid-19 vaccine eight months after receiving their second dose.

In that case, up to 5.2 million people may be eligible to receive a booster shot, or a third dose, of a COVID-19 vaccine during the week of September 20, if the booster program begins then.

CDC data shows that about 3.4 million US residents were fully vaccinated by January 20, making them eligible for a booster shot eight months later, on September 20. Up to 5.2 million people may be eligible for their booster shot at the end. of the week.

The initial launch of boosters is on track to include doses of Pfizer / BioNTech, pending clearance from the FDA, but it may take a few more weeks to advance the Moderna vaccine boosters.

More than half, 56%, of the doses administered through January 20 were Pfizer / BioNTech doses, CDC data shows. In December, the FDA cleared the Pfizer / BioNTech vaccine for emergency use about a week before the Moderna vaccine.

Public health officials and medical experts from the U.S. Department of Health and Human Services (HHS) noted in a joint statement in August that the booster rollout could be staggered by default since the initial rollout of the first dose was staggered.

For example, if boosters are recommended for people six to eight months after receiving their second dose, healthcare workers and older adults will likely be the first eligible group to receive booster shots if implemented next week .

If someone got their second dose in January, that was eight months ago. March was six months ago.

“At that time, people who were fully vaccinated prior to the vaccine launch, including many healthcare providers, nursing home residents and other seniors, will likely be eligible for a booster,” the statement said. “We would also begin efforts to administer booster vaccines directly to residents of long-term care facilities at that time, given the distribution of vaccines to this population at the beginning of the vaccine launch and the continued increased risk that covid- 19 represents for them “.

The FDA and CDC previously approved the authorization of third doses for immunosuppressed individuals. More than 1.9 million people have already received an additional dose since mid-August, according to the CDC.

– Trends Wide’s Virginia Langmaid and Deidre McPhillips contributed to this report.