The FDA said an updated analysis of the vaccine showed a risk of blood clots as a side effect — which were first linked to the vaccine last April in Europe.
The FDA now recommends the J&J vaccine for anyone for "whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine."
A similar recommendation was issued by the U.S. Centers for Disease Control (CDC) in December.
In a statement to Yahoo Finance, the company said the data continue to show it's a relatively safe option for adults, compared to not taking a vaccine and the risk of contracting COVID-19.
"Our number one priority is the safety and well-being of those who use the Johnson & Johnson COVID-19 vaccine. Language about the risk of TTS (thrombocytopenia syndrome) has been added to the first page of the Fact Sheet to increase its prominence. This update further highlights the potential risk of TTS and does not reflect a change in the rate of cases observed," the statement said.
J&J's vaccine has faced concern over potential blood clots since April 2021, when the European Medicines Agency (EMA) first announced a link between clots and the adenoviral vector vaccine.
The EMA's safety advisory committee said then that "a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen. PRAC also concluded that these events should be listed as very rare side effects of the vaccine."
The FDA soon followed suit announcing it would look into the issue as well. Since then, the CDC has seen studies showing that the mRNA vaccines from Pfizer (PFE)/BioNTech (BNTX) and Moderna (MRNA) are preferred as a first dose and provide better protection as booster doses to a J&J primary dose. The mRNA vaccines have proved highly effective against the virus, but wane quickly. By comparison, J&J has reiterated that while its efficacy isn't as high, it provides protection for a longer period of time.
The FDA's Peter Marks told STAT Thursday that the agency is not saying the vaccine is bad.
But the risk of clots has caused concern among recipients of the vaccine, as well as slowed demand for the vaccine overseas.
When it first launched, J&J's vaccine met all the global requirements to help alleviate the pandemic. It was a cheap vaccine, at $5 per dose, and easy to administer — not requiring ultra-cold storage like mRNAs. In addition, it only required one dose compared to the mRNA vaccines' two doses. But the EMA's announcement of blood clot risk, especially in adult women, raised concern globally.
The vaccine was being produced in South Africa, and was under pressure to distribute domestically, even though its use was suspended over blood clot concerns in April 2021.
But after the distribution agreement with Aspen Pharmacare was put in place, demand continued to wane, despite calls from the World Health Organization for vaccine companies to do more to support vaccinations in Africa. In fact, Aspen announced earlier Thursday that it would shift half of its COVID-19 vaccine production capacity to other products if demand didn't pick up in the next six weeks.
Dr. Leana Wen, an emergency physician and former Baltimore health commissioner, told Yahoo Finance that the FDA's decision doesn't erase the fact that the J&J vaccine still provides some benefits and protection for some populations.
"There are some people who have severe allergies (very rare) or (more common) such distrust of mRNA technology that they won't get vaccinated with Pfizer or Moderna," Wen said.
And because of its ease of storage, it should still a desirable type of vaccine for some parts of the world, she said.
The J&J vaccine, developed by the company's Janssen unit, accounts for 41% of U.S. COVID-19 vaccine donations to low-income countries, according to KFF. That's the highest percentage among all countries. J&J accounts for 12% of the country's total donations globally.
Blood clots were first associated with COVID-19 vaccines when the EMA investigated similar reports after the AstraZeneca (AZN) vaccine, which uses a similar technology as J&J's, and was similarly sidelined for the mRNA vaccines. The WHO issued a recommendation that mRNA or other vaccines are more favorable as booster doses after AstraZeneca.
Follow Anjalee on Twitter @AnjKhem