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US officials are urging a go-slow approach on the possibility of a third booster shot for Pfizer/BioNTech's covid vaccine (Source:photo illustration/Alamy image)

Preparations for a streamlined global review and approval process for coronavirus vaccine booster shots already are underway, even though there is not universal agreement the additional shots are necessary.

Before Pfizer Inc. made waves last week by signaling it would soon file an application for a booster shot, Peter Marks, director of the US Food and Drug Administration’s Center for Biologics Evaluation and Research, said global regulators are discussing a harmonized approval process.

“Regulators are already having these conversations about how we’re going to come together and try to mirror something that looks more like the WHO process for influenza,” Marks said on 30 June during the DIA Global Annual Meeting.

CBER Director Peter Marks

“If we start to see different variants in different parts of the globe it could be a little challenging, but I do think we need to harmonize as much as we possibly can or else we will have issues,” he said.

The FDA annually approves a World Health Organization-recommended set of selected flu strains to be used in the flu vaccine to be administered. (Dearth Of Seasonal Flu Adds Uncertainty To Vaccine Strain Selection For Next Season)

Before a booster can be approved, criteria are needed for determining the need for a modified shot, along with a selection process for antigens to include in the product, FDA officials have said. The FDA also has said that safety and immunogenicity data alone may not be enough to approve a booster. (Vaccines For COVID Variants Will Require Clinical Data US FDA Says)

Members of the CDC’s Advisory Committee on Immunization Practices also have said that falling antibody levels or high breakthrough infection totals may prompt consideration of a booster shot. (COVID19 Vaccines Declining Antibody Levels Breakthrough Infections Could Spur Booster Recommendations)

In addition to the talk of boosters, Pfizer/BioNTech and Moderna, Inc. are seeking full approval of biologics license applications for their COVID-19 vaccines. (When Should COVID Vaccines Get Full Approval US FDA Squeezed By Too Fast And Too Slow Camps)

Feds Want More Data, But Pfizer Filing Position Unchanged

Pfizer briefed federal officials on 12 July on its preliminary booster data and ongoing vaccine trials.

The company said in a statement that it “and the US government share a sense of urgency in staying ahead of the virus that causes COVID-19, and we also agree that the scientific data will dictate next steps in the rigorous regulatory process that we always follow.”

“We look forward to publishing more definitive data in a peer-reviewed journal and continuing to work with regulatory authorities to ensure that our vaccine continues to offer the highest degree of protection possible,” Pfizer said.

Prior to the briefing, Pfizer and partner BioNTech SE indicated that they intend to seek emergency use authorization for a booster shortly after data is shared in August. Pfizer said on 13 July that its pre-briefing position had not changed and that the data will dictate its next steps in the regulatory process.

After Pfizer suggested a booster shot may be needed sooner rather than later, the FDA and Centers for Disease Control and Prevention pushed back, arguing there is no evidence a booster shot is necessary at this time. (To Boost Or Not To Boost Pfizer FDA And The COVID Vaccine Communication Challenge)

Meanwhile, federal officials maintained their pre-briefing position that booster shots are not necessary at this time.

The Health and Human Services Department said its officials appreciated the information and “continue to engage in a science-based rigorous process to consider whether, when, or for whom a booster might be necessary.”

“The administration is prepared for booster doses if and when the science demonstrates that they are needed, and any recommendation by CDC and FDA would come after their thorough review process,” HHS added. “Officials will continue to review any new data as it becomes available.”

During a 13 July media briefing sponsored by the Infectious Diseases Society of America, CDC Deputy Director for Infectious Diseases Jay Butler reiterated that there is no evidence of waning immunity among people who were vaccinated in December 2020 or January 2021.

“The top priority is for people to get that first dose and that first series to be protected against COVID-19 as soon as possible,” Butler said. “The question about boosters is one that is being intensively reviewed and there is ongoing study to accumulate more data on that.”

“Our interest is to be able to be ready if boosters are needed,” he added in response to a later question on booster shots.

Johnson & Johnson, the third company with a COVID-19 vaccine EUA, also told the Pink Sheet that there is no evidence to suggest a booster is needed for its product.

“Durability of immune response of a single dose of the Johnson & Johnson COVID-19 vaccine has been measured up to 239 days to date and remains robust,” the company said.

J&J’s vaccine is about to get change unrelated to boosters: The FDA decided to add a new warning of Guillain-Baré Syndrome to the J&J vaccine label after about 100 cases were reported. The ACIP is expected to discuss the issue at an upcoming meeting. (COVID19 Vaccine Safety Now Soft Rollout Not Pause After Reports Of GuillainBarr Syndrome)

An ACIP meeting has been scheduled for 22 July to discuss COVID-19 issues, but no agenda was available at press time on 13 July.

A Good Place To Start

National Institutes of Health Director Francis Collins also wrote in a 13 July blog post that an NIH-funded study published in the journal Nature suggested the immune response from the Pfizer/BioNTech mRNA vaccines may be strong and persistent for years. He said more study is needed, but the data add to the evidence that a booster shot for the mRNA vaccine may not be needed “for quite some time” unless COVID-19 evolves into new variants that can evade the vaccine-induced immunity.

Collins also addressed the “bit of a dust-up” between Pfizer’s statements on the need for a booster versus the FDA and CDC’s suggestion they are not warranted yet.

“We’ve still got a lot more to learn about the immunity generated by the mRNA vaccines,” Collins wrote. “But this study – one of the first in humans to provide direct evidence of germinal center activity after mRNA vaccination – is a good place to continue the discussion.”

Andrew Pavia, chief of the University of Utah School of Medicine’s Division of Pediatric Infectious Diseases, also called for patience during the IDSA briefing.

“This is an area where everyone wants an answer before we have data,” he said. “Everyone’s going to keep asking the question, but we’re not going to know the answer until the answer is in.”

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