The Food and Drug Administration team endorsed Johnson & Johnson’s Covid-19 vaccine for emergency use, a critical step in bringing a third injection to the U.S. market.
The team report released on Wednesday aims to inform the FDA Vaccine and Related Biological Products Advisory Committee, which will meet on Friday to review J&J’s request for emergency use authorization.
During similar requests by Pfizer and Moderna, the agency authorized the vaccination of these companies the day after the committee of external medical consultants supported the emergency use authorization. The committee should recommend the J&J vaccine. The FDA does not need to follow the committee’s recommendations, but it often does.
The FDA team said it determined that clinical trial results and safety data were “consistent with the recommendations set out in the FDA’s Guidance for Emergency Use of Vaccines to Prevent COVID-19”.
J&J presented the Covid vaccine data to the FDA on February 4. The level of protection for the vaccine varied by region, J&J said, with the injection showing 66% overall effectiveness, 72% in the United States, 66% in Latin America and 57% in South Africa, where variant B.1.351 is spreading quickly. The company said the vaccine prevented 100% of hospitalizations and deaths.
On February 5, there were seven Covid-19-related deaths in the study in the placebo group and no Covid-19-related deaths in the vaccine group, the FDA said.
There were no reports of anaphylaxis, a serious and potentially fatal allergic reaction, according to the report. The FDA said the most common side effects reported were headache and fatigue, followed by muscle pain, nausea and fever.
The vaccine’s effectiveness was similar across age, race and people with comorbidities, the FDA team said. However, the effectiveness appeared to be less in people 60 and older who also had comorbidities, such as diabetes or heart disease, the agency said.
The news comes as the Biden government works to increase the supply of doses, after states complained that the demand for injections was quickly outstripping the supply. Approximately 44.1 million of about 331 million Americans received at least their first dose of Pfizer and Moderna’s two-dose vaccines, according to data compiled by the Centers for Disease Control and Prevention. More than 19 million have already received their second chance.
If approved, J&J’s order would be the third Covid-19 vaccine authorized for emergency use in the United States, following those developed by Pfizer-BioNTech and Moderna. The Pfizer vaccine was authorized on December 11, and Moderna obtained authorization a week later. The J&J vaccine requires only one dose, which would make logistics easier for healthcare professionals.
This authorization is not the same as full approval, which can usually take months longer. J&J, like Pfizer and Moderna, submitted only two months of safety data, but the agency usually requires six months for full approval. J&J is seeking authorization for use with people aged 18 and over.
J&J has an agreement with the federal government to provide 100 million doses of its vaccine by the end of June. Jeff Zients, President Joe Biden’s Covid czar, told reporters last week that the company is unlikely to have a “large stock” of doses ready before its launch in the United States, with only a few million doses manufactured.
The company said it plans to ship the vaccine, which contains five doses per bottle, between 36 and 46 degrees Fahrenheit. In comparison, the Pfizer vaccine needs to be stored in deep-frozen freezers that keep it between minus 112 and minus 76 degrees Fahrenheit. Moderna’s vaccine needs to be sent between 13 degrees below and 5 degrees above zero Fahrenheit.