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 nationwide. .
The FDA’s emergency use authorization on Saturday begins the federal government’s plan to distribute about 4 million doses of J&J vaccine to states, pharmacies and community 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 temperature for months.
The J&J vaccine “makes it easier to operate operationally in many contexts,” Dr. Nancy Messonnier, director of the CDC’s National Center for Vaccination and Respiratory Diseases, told the American Medical Association magazine during a question and answer event. “I hope there are many considerations that state health departments have around these vaccines, more about the ease of use of the J&J vaccine and how it might be more appropriate for some populations.”
Initially, doses would be limited, J&J said. The company expects to deliver 20 million doses by the end of March, J&J’s U.S. vice president of medical affairs, Dr. Richard Nettles. J&J has an agreement with the U.S. government to supply 100 million doses of its vaccine by the end of June, and U.S. officials say they are working with the company to increase supply as quickly as possible.
In recent weeks, U.S. health officials have pushed Americans to get vaccinated as quickly as possible. Officials are increasingly concerned about new emerging variants of the virus, in particular strain B.1.351, which has been shown to reduce the effectiveness of vaccines both in the market and in development. On Friday, the head of the Centers for Disease Control and Prevention, Dr. Rochelle Walensky, warned that the declines in Covid-19 cases reported in the U.S. since early January may be flattening as the disease spreads. variants.
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 a trait that showed 66% overall effectiveness, 72% in the United States, 66% in Latin America, and 57%. in South Africa, where variant 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 prevented 100% of hospitalizations and deaths.
The Pfizer vaccine was found to be 95% effective against the prevention of Covid-19, while that of Moderna was about 94% effective. Infectious disease experts noted that the J&J figures cannot be used as a direct comparison with the other two vaccines, as it is a single dose and the company’s trial was conducted when there was more infections, as well as new, more contagious variants.
The FDA has indicated that it would authorize a vaccine against Covid-19 that is safe and has a minimum efficacy of 50%. In comparison, the flu vaccine generally reduces the risk of getting the flu by 40% to 60% compared to people who are not inoculated, according to the CDC.
The FDA authorized the J&J vaccine for people over 18 years of age. It’s not the same as full approval, which requires more data and can usually take a few more months. J&J, like Pfizer and Moderna, has submitted only two months of security data, but the agency usually requires six months for full approval. The FDA approved the emergency use of hydroxychloroquine to treat Covid-19 in March, only to revoke it in June after additional data showed it provided “no evidence of benefit” in patients with coronavirus.
The FDA was expected to approve the J&J vaccine for emergency use.
The agency’s announcement comes after a key group unanimously backed the emergency use vaccine on Friday. While the FDA should not follow the advisory committee’s recommendation, it often does.
After the vote, Dr. Archana Chatterjee, an infectious disease expert at Chicago Medical School and a voting member of the committee, said the J&J vaccine will help “meet the needs of the moment,” as states complain. that there is not enough supply from Pfizer and Modern. vaccines.
“We need to get this vaccine out now,” said Dr. Jay Portnoy, a professor at UMKC School of Medicine and a member of the voting committee, after the vote. He added, “we are in a hurry,” as the variants pose a threat to the nation’s progress in the pandemic.
No specific safety issues were identified for the J&J vaccine. Headaches, fatigue, and muscle pain were some of the most common side effects among people who received the inoculation, according to an FDA report. published Wednesday. Nausea, fever and pain at the injection site were also reported, according to the report.
Macaya Douoguih, head of clinical development and medical affairs for the J&J vaccine division, Janssen, told the FDA group on Friday that two people suffered severe allergic reactions shortly after receiving the vaccine. One of the people was participating in an ongoing trial in South Africa and developed anaphylaxis, a severe and life-threatening allergic reaction.
The company has said it plans to send the vaccine, which contains five doses per vial, between 36 and 46 degrees Fahrenheit. In comparison, the Pfizer vaccine should be stored in ultra-cold freezers that keep it between 112 and 76 degrees Fahrenheit, although the FDA recently allowed the company to store its vaccine for two weeks at temperatures that they are commonly found in pharmaceutical freezers. The Moderna vaccine should be sent 13 degrees below 5 degrees above zero Fahrenheit.
This is a developing story. Please check for updates again.