Food and Drug Administration officials endorsed Johnson & Johnson’s emergency Covid-19 vaccine, a crucial step in getting a third shot onto the U.S. market.
The employee report released on Wednesday is designed to brief the FDA’s Vaccines and Related Biological Products Advisory Panel, which will meet on Friday to review J & J’s application for emergency approval.
At a similar request from Pfizer and Moderna, the agency approved these companies’ vaccinations the day after the committee of external medical advisors endorsed approval for emergency use. The committee is expected to recommend J & J’s vaccine. The FDA does not need to follow the committee’s recommendation, but it often does.
FDA staff noted that the clinical trial results and safety data “are in accordance with the recommendations in the FDA guidelines on emergency approval of vaccines to prevent COVID-19.”
J&J submitted its Covid vaccine data to the FDA on February 4th. The vaccine’s level of protection varies from region to region, J&J said, with the shot showing an effectiveness of 66% overall, 72% in the US, 66% in Latin America and 57% in South Africa, where variant B.1.351 is spreading rapidly. The company said the vaccine prevented 100% of hospital stays and deaths.
As of February 5, there were seven Covid-19-related deaths in the placebo group and no Covid-19-related deaths in the vaccine group, according to the FDA.
According to the agency, no specific safety concerns were identified when analyzed by age, race and comorbidities. According to the report, there have been no reports of anaphylaxis, a serious and potentially life-threatening allergic reaction. The FDA said the most common side effects were headache and fatigue, followed by muscle pain, nausea, and fever.
The vaccine’s effectiveness was similar for age, race, and people with comorbidities, according to FDA staff. However, the effectiveness appeared to be less in people aged 60 and over who also had comorbidities such as diabetes or heart disease. The effectiveness rate was 42.3% about a month after the shot.
As of January 22, eight pregnancies had been reported, four of them in the vaccine group, to FDA staff. Among the participants in the vaccine group, two pregnancies are ongoing with currently unknown results, according to the report.
The news comes as the Biden government works to increase the supply of cans after states complained that demand for the shots was rapidly exceeding supply. Around 44.1 million out of around 331 million Americans have received at least their first two-dose dose of the Pfizer and Moderna vaccines, according to the Centers for Disease Control and Prevention. More than 19 million have already received their second shot.
If approved, J & J’s application would be the third Covid-19 vaccine to be approved in the U.S. after the emergency vaccines developed by Pfizer-BioNTech and Moderna. Pfizer’s vaccine was approved on December 11th, and Moderna received approval a week later. J & J’s vaccine only requires one dose, which would make logistics easier for healthcare providers.
Such authorization is not the same as full approval, which can typically take months longer. J&J, like Pfizer and Moderna, has only submitted safety data for two months, but the agency typically takes six months for full approval. J&J is applying for permission to use it on anyone aged 18 and over.
J&J has signed a contract with the federal government to supply 100 million doses of its vaccine by the end of June. Jeff Zients, President Joe Biden’s Covid Tsar, told reporters last week that the company is unlikely to hold a “large inventory” of cans prior to launch in the US, as only a few million cans are manufactured.
The company has announced that it will ship the vaccine, which contains five doses per vial, at 36 to 46 degrees Fahrenheit. In comparison, Pfizer’s vaccine must be stored in ultra-cold freezers that are between minus 112 and minus 76 degrees Fahrenheit. Moderna vaccine must be shipped at 13 to 5 degrees above zero Fahrenheit.