Food and Drug Administration staff have approved Johnson & Johnson’s Covid-19 vaccine for emergency use, a critical step in bringing a third blow to the US market.
The personnel report released Wednesday is intended to inform the FDA Advisory Committee on Vaccines and Related Biological Products, which will meet Friday to review J & J’s application for emergency use authorization.
During similar requests by Pfizer and Moderna, the agency authorized the vaccinations of those companies one day after the Committee of External Health Advisers upheld the emergency use authorization. The committee is expected to recommend the J&J vaccine. The FDA does not have to follow the committee’s recommendations, but it often does.
FDA staff said it determined that the results of the clinical trials and safety data were “in accordance with the recommendations set forth in the FDA Emergency Use Authorization Guidelines for Vaccines to Prevent COVID-19.”
J&J submitted its Covid vaccine data to the FDA on February 4th. The level of vaccine protection varied by region, J&J said, with one hit showing 66% effectiveness overall, 72% in the United States, 66% in Latin America and 57% in South Africa, where variant B.1.351 it spreads rapidly. The company said the vaccine prevented 100% of hospitalizations and deaths.
As of Feb. 5, there were seven Covid-19-related deaths in the placebo group and no Covid-19-related deaths in the vaccine group, the FDA said.
According to the report, no anaphylaxis, a severe and life-threatening allergic reaction, has been reported. The FDA said the most common side effects reported were headache and fatigue, followed by muscle aches, nausea and fever.
The effectiveness of the vaccine was similar in age, race and people with comorbidities, FDA staff said. However, the effectiveness seems to be lower in people aged 60 or older who also had comorbidities, such as diabetes or heart disease, the agency said.
The news comes as the Biden administration is working to increase the supply of doses, after states complained that demand for photos is rapidly exceeding supply. About 44.1 million of the approximately 331 million Americans received at least their first dose of two-dose Pfizer and Moderna vaccines, according to data compiled by the Centers for Disease Control and Prevention. More than 19 million have already received the second blow.
If approved, the J&J app 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 received authorization a week later. The J&J vaccine requires a single dose, which would make logistics easier for healthcare providers.
Such an authorization is not the same as a full approval, which can usually take several months. J&J, like Pfizer and Moderna, only sent two months of safety data, but the agency usually needs six months for full approval. J&J requires authorization for use by persons 18 years of age and older.
J&J has an agreement with the federal government to provide 100 million doses of vaccine by the end of June. Jeff Zients, President Joe Biden’s Tsar Covid, told reporters last week that the company probably won’t have a “large inventory” of pre-launch doses in the United States, with only a few million doses manufactured.
The company said it intends to deliver the vaccine, which contains five doses per bottle, at 36 to 46 degrees Fahrenheit. By comparison, the Pfizer vaccine should be stored in ultra-cold freezers, which keep it between minus 112 and minus 76 degrees Fahrenheit. The Moderna vaccine should be transported at 13 below 5 degrees above zero Fahrenheit.