Johnson & Johnson coronavirus vaccine gets green light to resume distribution

Johnson & Johnson coronavirus vaccinations can resume immediately, federal regulators said late Friday, agreeing with a recommendation from a federal advisory panel that the shot’s benefits outweigh its risks. 

The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), which had jointly recommended a nationwide pause 10 days ago, accepted the recommendation from the CDC’s Advisory Committee on Immunization Practices.

Vaccination sites across should be able start administering the shots as early as Saturday morning. 

There are about 9.5 million doses of the vaccine sitting on shelves across the country that could be deployed immediately, and states were already reacting in the hours after the panel’s vote.

Pharmacies and hospitals were also preparing to resume giving the J&J shot. CVS said it would make appointments available at its pharmacies next week. A spokesman said “all warnings and precautions will be communicated throughout the vaccination process.”

“This is not a decision the agencies reached lightly. Medical and scientific teams of both the FDA and CDC reviewed several sources of information and data related to the Janssen COVID-19 vaccine to reach today’s assessment,” acting FDA Commissioner Janet Woodcock said during a press briefing.

The FDA will update fact sheets given to patients at the vaccination site, as well as instructions for vaccine providers and health providers that include warnings of the risk of a rare complication involving blood clots in women under the age of 50. 

CDC Director Rochelle Walensky said the agency has been focusing most of its outreach in the past week on providers, like the American College of Obstetricians and Gynecologists, who would be treating younger women. 

Johnson & Johnson has also already negotiated language with the FDA, a company official told the CDC panel on Friday.

The FDA and CDC told states to temporarily stop using the vaccine last week out of an abundance of caution amid concerns over six cases of the clotting condition. 

On Friday, officials said they were aware of 15 cases of the unusual clots amid nearly 8 million shots administered. All were women, most of them under 50. Three died, and seven remain hospitalized.

“Above all else, your health and safety come first. The American public should feel reassured about the safety systems and protocols that we have in place around the COVID-19 vaccines,” Walensky said. 

The Biden administration has ordered enough vaccines from Pfizer-BioNTech and Moderna to cover all American adults without the help of J&J, but public health experts have grown increasingly concerned about the impact of the pause, especially on vaccine hesitancy. 

Even with the pause lifted, Johnson & Johnson is still facing major supply issues. Distribution of the vaccine to states has been extremely uneven, and it’s not clear how quickly the company can ramp up production.

Johnson & Johnson’s goal of delivering 100 million doses by the end of May could be in jeopardy as a result of a government investigation into Emergent BioSolutions, which contracts with J&J to manufacture vaccines in Baltimore.

Emergent produced tens of millions of doses of Johnson & Johnson’s vaccine, but the FDA launched an investigation that has unveiled serious safety and cleanliness issues. The agency has ordered a pause on manufacturing at the plant while the problems are addressed. No vaccines can be distributed until the FDA certifies the plant.