J&J is 66% efficient, however a single shot can fall brief towards variations

Johnson & Johnson said on Friday its single-dose coronavirus vaccine was 66% overall effective against Covid-19. However, the vaccine appeared to be less effective against other variants.

The Food and Drug Administration has announced that it will approve a vaccine that is safe and at least 50% effective. In comparison, the flu vaccine generally reduces people’s risk of influenza by 40% to 60% compared to people who are not vaccinated, according to the Centers for Disease Control and Prevention.

The level of protection varies from region to region, J&J said, with the vaccine showing a total of 66% effectiveness after four weeks, 72% in the US, 66% in Latin America and 57% in South Africa.

J&J said the vaccine was 85% effective in preventing serious illness in all adults four weeks after vaccination. The vaccine provided full protection against hospitalizations related to Covid four weeks after vaccination.

“We are proud to have reached this critical milestone and our commitment to addressing this global health crisis is urgent for everyone, everywhere,” said Alex Gorsky, CEO of J&J, in a statement.

J & J’s shares closed about 3% on a wider market sell-off. Shares in Novavax, which is also developing a Covid-19 vaccine, closed more than 64% and shares in Moderna rose about 8%.

The highly anticipated results were based on 468 confirmed Covid-19 infections among the more than 43,000 volunteers in the phase three study, according to J&J. The company said the study includes those infected with B.1.351, the new, highly contagious strain in South Africa.

Efficacy against serious illnesses increased over time, with no cases reported in vaccinated participants after day 49, according to the company. Protection was consistent across race and age, including those over 60.

“Important and wonderful development”

Dr. Anthony Fauci, the nation’s leading infectious disease expert, said the main finding of the data was that the vaccine could keep people out of the hospital and save them from serious illness.

“The most important thing, more important than whether you prevent someone from getting pain and a sore throat, is to prevent people from getting serious illness,” said the director of the National Institute for Allergies and Infectious Diseases in an interview with reporters. “That will ease so much stress and human suffering and death in this epidemic.”

J&J said the vaccine was well tolerated and no major safety concerns were reported with the vaccine, including anaphylaxis.

Dr. Scott Gottlieb, a former FDA commissioner, called the J&J data “fantastic” and said in a tweet that the vaccine produced “sustained (and increasing!) Immune protection over time.”

“This one-shot vaccine has been very effective in preventing serious diseases, even with new variants,” he said. “The disease environment is now more complex. Even in the United States, the studies being done today are looking at more mutated cases. Make no mistake: this is an important and wonderful development.”

US officials and Wall Street analysts are eagerly anticipating J & J’s vaccine approval, which could come as early as next month. Public health officials and infectious disease experts say world leaders will need a range of drugs and vaccines to beat the virus that killed more than 400,000 Americans in about a year.

The new data also comes as U.S. health officials, including Fauci, are concerned that vaccines currently on the market may not be as effective at protecting against new, more contagious strains of the coronavirus. Moderna said Monday it was working on a booster shot to protect against the strain in South Africa. Pfizer and Novavax also said they will test modified vaccines.

Dr. Paul Offit, director of the Vaccine Education Center at Philadelphia Children’s Hospital, said the new strains weren’t a problem yet, but it was important that drug makers prepare for the possibility that the virus could mutate enough to protect the current avoid vaccinations.

One shot means easier logistics

If J & J’s vaccine is FDA approved, it will be the third emergency vaccine approved in the United States after vaccines developed by Pfizer-BioNTech and Moderna. Pfizer’s vaccine was approved by the FDA on December 11, and Moderna’s vaccine was approved a week later.

Pfizer and Moderna vaccines require two doses three to four weeks apart. J & Js only require one dose, which makes logistics easier for healthcare providers.

Pfizer’s vaccine was found to be 95% effective against Covid-19, while Moderna’s vaccine was about 94% effective. Infectious disease experts, including Isaac Bogoch of the University of Toronto, pointed out that J & J’s numbers cannot be used as a direct comparison with the other two vaccines because it is a single dose and the company’s study is being conducted became when there were more infections and new ones. more contagious variants.

In addition, J&J has announced that it will ship the vaccine at 36 to 46 degrees Fahrenheit. Pfizer’s vaccine must be stored in ultra-cold freezers between negative 112 and negative 76 degrees Fahrenheit. Moderna vaccine must be delivered between 13 and 5 degrees Fahrenheit.

The Department of Health and Human Services announced in August that it had signed a contract with Janssen, J & J’s pharmaceutical subsidiary, worth approximately $ 1 billion for 100 million doses of its vaccine. The deal gives the federal government the opportunity to order another 200 million cans, according to the announcement.

Disclosure: Scott Gottlieb is a CNBC employee and a member of the boards of directors of Pfizer, genetic testing startup Tempus, health technology company Aetion Inc., and biotech company Illumina. He is also co-chair of the Healthy Sail Panel of Norwegian Cruise Line Holdings and Royal Caribbean.

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