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 use authorization on Saturday kicks off the federal government’s plan to distribute nearly 4 million doses of the J&J vaccine to states, pharmacies and community health centers across the country next week. Unlike Pfizer and Moderna vaccines, J&J’s single-dose 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 operationally easier in many contexts,” said Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, to the Journal of American Medical Association during a question and answer event on Friday . “I hope that many of the considerations that state health departments are having around these vaccines are 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, said J&J. The company expects to deliver 20 million doses by the end of March, Dr. Richard Nettles, vice president of medical affairs for the United States, Dr. Richard Nettles, told House legislators on Tuesday. J&J has an agreement with the United States government to supply 100 million doses of its vaccine by the end of June, and US officials say they are working with the company to increase supplies as quickly as possible.
In recent weeks, US health officials have urged Americans to get vaccinated as soon as possible. Authorities are increasingly concerned about new emerging variants of the virus, particularly the B.1.351 strain, which has been shown to reduce the effectiveness of vaccines both on the market and in development. On Friday, the head of the Centers for Disease Control and Prevention, Dr. Rochelle Walensky, warned that the drop in Covid-19 cases reported in the United States since early January may be decreasing as the variants spread.
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. 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 Covid-19 prevention, while Moderna was found to be about 94% effective. Infectious disease experts pointed out that the J&J figures cannot be used as a direct comparison with the other two vaccines because it is a single dose and the company’s test was carried out when there were more infections, as well as new, more contagious variants.
The FDA has indicated that it would authorize a Covid-19 vaccine that is safe and at least 50% effective. The flu vaccine, by comparison, generally reduces people’s risk of getting the flu by 40% to 60% compared to people who haven’t been inoculated, according to the CDC.
The FDA has authorized the J&J vaccine for people aged 18 and over. It is not the same as full approval, which requires more data and can take several 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. The FDA approved the emergency use of hydroxychloroquine to treat Covid-19 in March, only to revoke it in June, after additional data showed that 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 major panel on Friday unanimously supported the vaccine for emergency use. The FDA Vaccine and Related Biological Products Advisory Committee plays a key role in approving influenza and other vaccines in the U.S., making sure that vaccines are safe for public use. Although the FDA does not have to follow the recommendations of the advisory committee, it usually does.
After the vote, Dr. Archana Chatterjee, an infectious disease specialist 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 Pfizer and Modern vaccines.
“We need to launch this vaccine now,” said Dr. Jay Portnoy, a professor at the UMKC School of Medicine and a voting member of the committee, after the vote. He added: “We are in a hurry” as the variants pose a threat to the country’s progress in the pandemic.
No safety concerns specific to the J&J vaccine have been identified. 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 on Wednesday. There have also been reports of nausea, fever and pain at the injection site, the report said.
Macaya Douoguih, head of clinical development and medical affairs at the J&J Janssen vaccine division, told the FDA panel on Friday that two people suffered severe allergic reactions shortly after receiving the vaccine. One of the people was participating in an ongoing study in South Africa and developed anaphylaxis, a serious, life-threatening allergic reaction.
The company said it plans to ship the vaccine, which contains five doses per bottle, from 36 to 46 degrees Fahrenheit. In comparison, Pfizer’s vaccine needs to be stored in deep-frozen freezers that keep it between minus 112 and 76 degrees Fahrenheit, although the FDA recently allowed the company to store its vaccine for two weeks at temperatures commonly found in pharmaceutical freezers. Moderna’s vaccine needs to be sent between 13 degrees below and 5 degrees Fahrenheit.
This is a developing story. Please check again for updates.