CDC Breaks with Advisory Panel on Boosters, Recommends Broader Access

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A day after the U.S. Food and Drug Administration (FDA) authorized a COVID-19 booster dose of the Pfizer-BioNTech vaccine, a U.S. Centers for Disease Control and Prevention (CDC) advisory committee voted in support of it, with an additional population added into it.

The FDA authorized a third shot of the Pfizer-BioNTech vaccine for people over the age of 65, individuals at high risk for severe disease, and front-line healthcare workers. The shot can be given six months after they receive their second shot. Earlier, it was authorized for immuno-compromised individuals.

The CDC added to it, recommending boosters for people between the ages of 18 and 64 who are at increased risk of COVID-19 due to their work or living situation. The CDC took into account the FDA’s authorization and recommendations made by its own Advisory Committee on Immunization Practices (ACIP), which voted to recommend the third shots for people 65 and over and residents of long-term care facilities, and people from the age of 50 to 64 with underlying medical conditions. The addition of the 18-to-49 group was an extra recommendation by the CDC.

ACIP had voted 9-6 against recommending the extra shots for people ages 18 to 64 who are at risk related to their occupational or institutional situations.

“As CDC Director, it is my job to recognize where our actions can have the great impact,” stated Rochelle Walensky, M.D., M.P.H., director of the CDC. “At CDC, we are tasked with analyzing complex, often imperfect, data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good.”

The decisions by the FDA and CDC were largely based on data presented by Pfizer from the U.S. and Israel. Israel exclusively used the Pfizer-BioNTech vaccine and had a larger percentage of their population fully vaccinated earlier than most countries, including the U.S. The data has indicated that the efficacy of the COVID-19 vaccine wanes over time, in general, and specifically in the face of the more highly contagious Delta variant. An observational study in Israel showed that a third dose six months after a second shot restored protection against COVID-19 to 95%.

It’s possible that a booster may eventually be recommended for the general population, but currently, there is not enough data to support it. The existing vaccinations in the U.S., including Pfizer-BioNTech, Moderna and Johnson & Johnson’s one shot, all do an excellent job of preventing hospitalization and death, even with decreased efficacy. The FDA and CDC decisions do not affect the Moderna or J&J vaccines. Moderna has submitted to the FDA for boosters in the U.S. for people 18 years of age and older.

Walensky added, “I believe we can best serve the nation’s public health needs by providing booster doses for the elderly, those in long-term care facilities, people with underlying medical conditions, and for adults at high risk of disease from occupational and institutional exposures to COVID-19. This aligns with the FDA’s booster authorization and makes these groups eligible for a booster shot. Today, ACIP only reviewed data for the Pfizer-BioNTech vaccine. We will address, with the same sense of urgency, recommendations for the Moderna and J&J vaccines as soon as those data are available.”

In related news, Gaithersburg, Md.-based Novavax and its partner, Serum Institute of India, made a regulatory submission to the World Health Organization (WHO) for emergency use listing (EUL) of Novavax’ COVID-19 vaccine candidate. The submission to WHO is based on their previous submission to India’s regulators.

“Today’s submission of our protein-based COVID-19 vaccine to WHO for emergency use listing is a significant step on the path to accelerating access and more equitable distribution to countries in great need around the world,” said Stanley C. Erck, president and chief executive officer, Novavax. “It represents another major milestone in Novavax’s transformation into a commercial global vaccine company and reinforces the value of global collaboration and need for multiple approaches to help control the pandemic.”

In clinical trials, Novavax’s product generated fewer side effects than the mRNA vaccines from Pfizer-BioNTech and Moderna, yet had similar efficacy. Although unlikely to be of much use in the U.S., it is hopeful to add additional vaccine capacity to underserved countries around the world. The company is manufacturing vaccines at 20 plants globally and says it will have the capacity to produce 2 billion vaccines in 2022. However, according to a New York Times report in August, U.S. regulators have indicated that the main reason Novavax is running almost a year behind the other vaccine producers is because of poor quality control at its manufacturing sites. Novavax argues that a contract it inked with the U.S. government restricted its ability to manufacture doses, directing it to work with specific drug manufacturers.

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