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Johnson & Johnson has applied to the Food and Drug Administration for the coronavirus vaccine for emergencies to obtain emergency clearance after releasing information last week showing that it is approximately 66% effective in protecting against the virus.
If J & J’s application is approved, it’s the third Covid-19 vaccine to be approved for emergency use in the US, behind those developed by Pfizer-BioNTech and Moderna. Pfizer’s vaccine was approved by the FDA on December 11, and Moderna’s was approved a week later.
“Today’s submission of emergency permits for our COVID-19 vaccine for investigations is an important step towards reducing the disease burden on people worldwide and putting an end to the pandemic,” said J & J’s chief scientific officer , dr. Paul Stoffels, said. in a statement.
“After approving our COVID-19 vaccine for emergency use, we are ready to begin shipping,” he said. “With our submission to the FDA and our ongoing investigations with other health authorities around the world, we are working with great urgency to make our research vaccine available to the public as soon as possible.”
U.S. officials and analysts on Wall Street are expecting the approval of the J&J vaccination, which could take place as early as this month. President Joe Biden is trying to increase the rate of vaccinations in the US, and experts believe his government needs a variety of drugs and vaccines to defeat the virus, which has killed more than 450,000 Americans in the past year, according to information by Johns Hopkins University.
Unlike Pfizer and Moderna’s vaccines, which require two doses given approximately three to four weeks apart, J & J’s medication requires only one dose, which facilitates the logistics for health care providers.
J&J said on January 29 that the vaccine is 66% effective against protection against Covid-19. However, the vaccine appears to be less potent against other variants. The level of protection was only 57% in South Africa, where a new, highly contagious strain called B.1.351 is spreading rapidly. South Carolina officials last month tracked down the first known U.S. case of the tribe.
Experts in infectious diseases point out that the numbers of J&J can not be used as a direct comparison with the vaccines of Pfizer and Moderna, which are 95% and 94% effective respectively. This is because J & J’s vaccine is a single dose and that the company’s trial was conducted when there were more infections and new, more contagious variants, they said.
Dr Anthony Fauci, the country’s leading expert on infectious diseases, said the main finding of the J&J data was that the vaccine appears to be 85% effective in preventing serious diseases.
“The most important thing, more important than whether you prevent someone from hurting and sore throat, is to prevent people ‘from getting serious diseases, the director of the National Institute of Allergy and Infectious Diseases said in a call with reporters on Jan. 29. “It will alleviate so much tension and human suffering and death in this epidemic.”
The FDA has indicated that it authorizes a vaccine that is safe and at least 50% effective. According to the Centers for Disease Control & Prevention, the flu vaccine reduces the risk of getting the flu by 40% to 60% compared to people who are not vaccinated.
J&J said they plan to send the vaccine at 36 to 46 degrees Fahrenheit. By comparison, Pfizer’s vaccine should be stored in ultra-cold freezers that keep it between negative 112 and negative 76 degrees Fahrenheit. The Moderna vaccine should be sent between negative 13 and 5 degrees Fahrenheit.
The Department of Health and Human Services announced in August that it had reached an agreement with Janssen, J & J’s pharmaceutical subsidiary, worth approximately $ 1 billion for 100 million doses of the vaccine. According to the announcement, the federal government has the option to order an additional dose of 200 million.