An influential advisory committee at the Centers for Disease Control and Prevention unanimously approved the booster of Moderna and Johnson & Johnson’s Covid-19 vaccines on Thursday and passed the recommendation for final approval to CDC Director Dr. Rochelle Walensky continues.
The Agency’s Advisory Committee on Immunization Practices recommended the Moderna booster for the elderly and at-risk adults six months after completing their first series of vaccinations to align with the distribution plan for Pfizer and BioNTechs boosters. It also advocated J&J boosters for anyone 18 and older who received their first vaccination at least two months ago.
The panel failed to specify which vaccine to use as a booster, leaving it up to doctors to decide whether to mix and match the companies’ doses to provide the best protection for patients.
More than 39 million Moderna recipients and nearly 13 million J&J recipients could be eligible for a booster dose as early as Friday, according to a slide presented by the CDC during the meeting.
Booster vaccination has been a controversial issue for scientists – inside and outside of government – especially since many people in the US and other parts of the world have not yet received a single dose of a vaccine. The World Health Organization has asked wealthy countries to wait before distributing boosters, and some scientists say they are not convinced that most Americans need them now.
Before the vote, some members said they were concerned about the lack of data on boosters, while others asked the agency if they could simplify the process of communicating who can get the extra doses.
“These recommendations kind of ask the person to decide about their underlying risk and medical condition, because the reality is that they do not consult their doctors in all cases; they just go out and get booster doses, ”said member Dr. Jason Goldmann.
“And I worry that if it’s too prescriptive or too verbose, we’ll either miss out on the opportunity to give boosters to people they really should get, or people just do it anyway and don’t necessarily have the support the language to do it, “he added.
The Biden administration hopes the extra dose will provide long-term and lasting protection for the U.S. population from serious illness, hospitalization, and death as the fast-paced Delta variant continues to spread and change. A newly discovered mutation in Delta is being investigated in the UK amid fears it could make the virus even more transmissible and further undermine Covid vaccines.
Walensky reached out to the committee ahead of Thursday’s vote, thanking them for their work and noting that data related to the virus and vaccines is constantly evolving.
“None of us can individually predict exactly what will happen next, and neither of us can individually know exactly what to do,” she told the panel. “Please know that I am listening here and eager to learn from your perspective.”
Moderna recipients can get a booster at half the dose of the two original shots.
The effectiveness of the two-dose vaccine against infections declines over time, according to the CDC before the committee meeting. Some studies also show a slight decrease in protection from hospitalization, mostly in those over 65, the data showed.
The CDC said the data were flawed, indicating that some recipients may have engaged in riskier activities after vaccination.
CDC official Dr. Tom Shimabukuro presented data showing that after vaccination with the Moderna or Pfizer vaccine, especially after the second dose, there is an increased risk of rare inflammatory heart disease, myocarditis and pericarditis.
The rare heart disease rate within seven days of vaccination was 10 cases per million doses, Shimabukuro said, citing a study by U.S. military personnel. It was common in young men and usually after the second dose, he said. Most patients reported feeling fully recovered within six weeks.
The surveillance is “ongoing,” he said.
Dr. Macaya Douoguih, director of clinical development and medical affairs at J&J vaccines division Janssen, said there is no data to suggest that people are at increased risk of developing a rare but serious blood clot disease after receiving a second dose. She presented data from the UK on second doses of AstraZeneca’s vaccine, which uses a platform similar to that of J&J.
However, an expert on the committee noted that earlier this year the UK authorities started restricting the use of AstraZeneca’s vaccine in young women because of the risk of rare blood clots, which means it could be difficult to assess the effects of a second dose of J&J based on this data.
