The FDA approves Johnson & Johnson’s single-shot Covid vaccine for emergency use
The Food and Drug Administration has approved Johnson & Johnson’s Covid-19 vaccine for emergency use. This gives the US a third tool to fight the pandemic as highly contagious variants are gaining a foothold across the country.
With the FDA’s approval for the emergency on Saturday, the federal government’s plan begins to distribute nearly 4 million doses of J & J’s vaccine to states, pharmacies and community health centers across the country next week. Unlike Pfizer and Moderna vaccines, patients with the single dose of J&J do not need to take a second dose and can be stored at refrigerator temperature for months.
J & J’s vaccine “makes it easier to use in many contexts,” said Dr. Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases of the CDC, told the Journal of the American Medical Association during a question and answer session on Friday. “I suspect that much of the national health consideration given to these vaccines is more about the ease of use of the J&J vaccine and how it might be better suited to some populations.”
Initially, doses would be limited, J&J said. The company expects to drop 20 million doses by the end of March, said Dr. Richard Nettles, vice president of medical affairs in the US, told the House legislature on Tuesday. J&J has signed a contract with the US government to supply 100 million doses of its vaccine by the end of June. US officials say they are working with the company to increase supply as soon as possible.
In the past few weeks, US health officials have urged Americans to get vaccinated as soon as possible. Officials are increasingly concerned about new, emerging variants of the virus, particularly strain B.1.351, which has been shown to reduce the effectiveness of vaccines both in market and in development. On Friday, the head of the Centers for Disease Control and Prevention, Dr. Rochelle Walensky, the declines in Covid-19 cases reported in the US since early January could flatten as the variants spread.
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. 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 all hospitalizations and deaths.
The Pfizer vaccine was found to be 95% effective against Covid-19, while the Moderna vaccine was about 94% effective. Infectious disease experts pointed out that J & J’s numbers cannot be used as a head-to-head comparison with the other two vaccines because it is a single dose and the company’s study was conducted when more infections, as well as new, more contagious variants occurred.
The FDA has announced that it will approve a Covid-19 vaccine that is safe and at least 50% effective. In comparison, the flu vaccine generally reduces the risk of developing influenza by 40% to 60% compared to people who were not vaccinated, according to the CDC.
The FDA has approved J & J’s vaccine for people 18 years of age and older. This is not the same as a full approval which requires more data and which can typically take several months longer. J&J, like Pfizer and Moderna, only submitted two months of safety data, but the agency typically takes six months for full approval. The FDA approved the emergency use of hydroxychloroquine to treat Covid-19 in March but revoked it in June after additional data showed it provided “no indication of benefit” in coronavirus patients.
The FDA was expected to approve J & J’s emergency vaccine.
The agency’s announcement comes after a key panel unanimously endorsed the emergency vaccine on Friday. The FDA’s Advisory Panel on Vaccines and Related Biological Products plays a key role in approving influenza and other vaccines in the United States and verifying that the vaccines are safe for public use. While the FDA does not need to follow the advisory board’s recommendation, it often does.
After the vote, Dr. Archana Chatterjee, an infectious disease expert at Chicago Medical School and voting committee member, said J & J’s vaccine will help “meet the needs of the moment” as states complain that there are insufficient supplies with Pfizer and Moderna gives vaccinations.
“We have to get this vaccine out now,” said Dr. Jay Portnoy, professor at UMKC School of Medicine and voting committee member, after the vote. He added, “We are in a hurry” as the variants pose a threat to the nation’s progress on the pandemic.
No specific safety concerns were identified with J & J’s vaccine. Headache, fatigue, and muscle aches were some of the most common side effects among people who received the vaccination, according to an FDA report released Wednesday. There have also been reports of nausea, fever and injection site pain, the report said.
Macaya Douoguih, director of clinical development and medical affairs for the vaccines division at J & J, Janssen, told the FDA panel on Friday that two people had severe allergic reactions shortly after receiving the vaccine. One of the people participated in an ongoing study in South Africa and developed anaphylaxis, a severe and life-threatening allergic reaction.
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. However, the FDA recently allowed the company to store its vaccine for two weeks at temperatures commonly found in pharmaceutical freezers. Moderna vaccine must be shipped at 13 to 5 degrees above zero Fahrenheit.
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