US Prepares for Wide Rollout of COVID-19 Boosters Next Month
US officials announced that health agencies in the country are preparing to widely distribute third doses of mRNA COVID-19 vaccines beginning the week of September 20, citing new data that point to waning protection over time. The move was unveiled in a statement signed by health leaders including acting FDA Commissioner Janet Woodcock, Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky and White House chief medical advisor Anthony Fauci.
Under the expanded plan, individuals would be offered a booster eight months after their second dose. People aged 65-plus and those in long-term care facilities are expected to get boosters initially, along with health workers and anyone else who was vaccinated first, according to the authorities. The third dose will be of the same vaccine from the two-dose regimen, according to people familiar with the plan.
‘Very clear’ now that protection declines
In the joint statement, US health officials said it has become “very clear” that immunity starts to dwindle after the initial two doses of Pfizer/BioNTech’s BNT162b2 and Moderna’s mRNA1293 – currently the only mRNA-based vaccines authorized for emergency use in the US – and with the dominance of the highly contagious Delta variant, “we are starting to see evidence of reduced protection against mild and moderate disease.”
They warned that “current protection against severe disease, hospitalization and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout.” The extra booster “will be needed to maximize vaccine-induced protection and prolong its durability,” the officials said.
Holding off for now on J&J booster
Meanwhile, recipients of Johnson & Johnson’s single-dose viral vector vaccine Ad26.COV2.S will probably need boosters as well, but officials are waiting to get more data “in the next few weeks” before making a formal recommendation. “With those data in hand, we will keep the public informed with a timely plan for Johnson & Johnson booster shots as well,” they said.
The FDA authorized third doses for certain immunocompromised patients last Friday, and while the CDC almost immediately recommended giving those doses, Woodcock reiterated the FDA’s previous stance that it saw no need to triple-vaccinate all other people “at this time.” Meanwhile, Pfizer and BioNTech reported Phase I booster data this week showing that an extra dose elicits significantly higher neutralizing antibodies against the original SARS-CoV-2 strain, compared to the two-dose primary schedule, as well as against the Beta and Delta variants.
BNT162b2 was granted an emergency-use authorization (EUA) in December 2020 to prevent COVID-19 in those aged 16 and older, with mRNA-1273 given the greenlight a week later for adults over 18. The FDA expanded the EUA for Pfizer and BioNTech’s jab in May to include adolescents 12 through 15 years of age. Meanwhile, Johnson & Johnson’s shot, which was authorized earlier this year, only started being administered in the US in March.