The Food and Drug Administration has approved Johnson & Johnson’s Covid-19 vaccine for emergency use, giving the United States a third tool to fight the pandemic as highly contagious variants begin to take root across the country.
The FDA’s emergency permit on Saturday launched the federal government’s plan to distribute nearly 4 million doses of J&J vaccine to states, pharmacies and health centers across the country next week. Unlike Pfizer and Moderna vaccines, the single-dose J&J regimen eliminates the need for patients to return for a second dose and can be stored at refrigerator temperatures for months.
The J&J vaccine “makes it operationally easier in many contexts,”
Initially, doses will be limited, J&J said. The company expects to deliver 20 million doses by the end of March, J&J Vice President of Medical Affairs Dr. Richard Nettles told House lawmakers on Tuesday. J&J has a deal with the US government to supply 100 million doses of its vaccine by the end of June, and US authorities say they are working with the company to increase supplies as quickly as possible.
In recent weeks, U.S. health officials have urged Americans to get vaccinated as soon as possible. Officials are increasingly concerned about new, emerging variants of the virus, especially strain B.1.351, which has been shown to reduce the effectiveness of vaccines both on the market and under development. On Friday, the head of the Centers for Disease Control and Prevention, Dr. Rochelle Valensky, warned that the reduction in Covid-19 cases reported in the United States since early January could be smoothed out as options spread.
J&J provided its Covid vaccine data to the FDA on February 4. The level of protection for the vaccine varies by region, J&J said, with the shot showing 66% effectiveness overall, 72% in the United States, 66% in Latin America and 57% in South Africa, where option B.1.351 is spreading rapidly. However, FDA documents show that the vaccine was 64% effective in South Africa after about a month. The company said the vaccine prevents 100% of hospitalizations and deaths.
The Pfizer vaccine was found to be 95% effective against preventing Covid-19, while Moderna was about 94% effective. Infectious disease experts said the J&J numbers could not be used as a direct comparison to the other two vaccines, as it was a single dose and the company’s study was conducted when there were more infections as well as new, more contagious ones. options.
The FDA has said it will authorize a Covid-19 vaccine that is safe and at least 50% effective. By comparison, the flu vaccine usually reduces the risk of infecting people with the flu by 40% to 60% compared to people who have not been inoculated, according to the CDC.
The FDA has approved the J&J vaccine for people over the age of 18. This is not the same as full approval, which requires more data and can usually take several months longer. J&J, like Pfizer and Moderna, provided only two months of safety data, but the agency typically requires six months for full approval. The FDA approved the emergency use of hydroxychloroquine to treat Covid-19 in March, only to cancel it in June after additional data showed it provided “no evidence of benefit” in patients with coronavirus.
The FDA is expected to approve the J&J vaccine for emergency use.
The agency’s announcement comes after a key panel unanimously endorsed the emergency vaccine on Friday. The FDA’s Advisory Committee on Vaccines and Related Organic Products plays a key role in approving flu and other vaccines in the U.S. use. Although the FDA should not follow the recommendations of the advisory committee, it often does.
After the vote, Dr. Archana Chatterjee, an infectious disease expert at Chicago Medical School and a member of the voting committee, said the J&J vaccine would help “meet the needs of the moment” as states complained that there was no sufficient supplies of Pfizer and Moderna vaccines.
“We need to get this vaccine out now,” said Dr. Jay Portnoy, a professor of medicine at UMKC and a member of the committee with the right to vote after the vote. He added, “We are in a hurry” as the options pose a threat to the nation’s progress in the pandemic.
No specific safety concerns have been identified for the J&J vaccine. Headaches, fatigue and muscle pain are among the most common side effects among people who have received the inoculation, according to an FDA report released Wednesday. Nausea, fever and pain at the injection site have also been reported, the report said.
Macaya Douoguih, head of clinical development and medical affairs at J&J Janssen’s vaccines department, told the FDA panel on Friday that two people had suffered severe allergic reactions shortly after receiving the vaccine. One of the people involved in an ongoing study in South Africa and developed anaphylaxis, a severe and life-threatening allergic reaction.
The company said it plans to deliver the vaccine, which contains five doses per vial, at 36 to 46 degrees Fahrenheit. In comparison, the Pfizer vaccine must be stored in ultra-cold freezers that maintain it between minus 112 and minus 76 degrees Fahrenheit, although the FDA recently allowed the company to store its vaccine for two weeks at temperatures common in pharmaceutical freezers. . The Moderna vaccine should be delivered at 13 below 5 to 5 degrees above zero Fahrenheit.
This is an evolving story. Please check again for updates.