Health Canada approves Johnson & Johnson COVID-19 vaccine
Johnson & Johnson has filed an application with the Food and Drug Administration (FDA) for an emergency use authorization for its coronavirus vaccine. According to the company, the drug is approximately 66% effective..
If the regulator satisfies statement J&J, their vaccine will be the third Covid-19 serum approved for use in the United States. First approvals received by Pfizer BioNTech and Moderna. Pfizer’s vaccine was approved by the FDA on December 11, and Moderna was given the green light a week later..
«Applying for emergency use of our vaccine is a key step towards reducing global disease and ending the pandemic», – Chief Scientist J&J, doctors Paul stoffels.
«We are ready to start shipping the vaccine as soon as we get approval from the regulator. Our team is doing everything necessary to make the drug as accessible as possible for the population.», – he said.
The FDA has scheduled a meeting of its Advisory Committee on Vaccines and Associated Biological Products for February 26.
«A public discussion by the committee of the evidence presented to support the safety and efficacy of Janssen Biotech’s Covid-19 vaccine will help provide a clear understanding of the decision on whether to allow the vaccine to enter the market. The FDA remains committed to keeping the public informed of the evaluation of Covid-19 vaccine data so that the community has confidence in the FDA-approved sera», – FDA’s acting commissioner said in a statement Janet woodcock.
American officials and Wall Street analysts eagerly awaiting vaccine approval J&J. It is known that Joe biden trying to speed up the pace of vaccination in the US.
Unlike Pfizer and Moderna vaccines, which require two doses three to four weeks apart, J&J offers only one go, making logistics easier for healthcare professionals.
January 29, J company&J said her vaccine was 66% effective overall. However, the drug can not boast of such a result everywhere. In particular, its effectiveness in South Africa, where a new strain of the virus appeared, was only 57%.
Infectious disease experts point out that the J numbers&J cannot be used as a direct comparison with Pfizer and Moderna vaccines, which were found to be 95% and 94% effective, respectively. The fact is that the J&J began to be carried out at a time when several new strains of coronavirus were observed around the world.
Doctor Anthony fauci, a leading national expert on infectious diseases, said that the most important takeaway from J&J was that the vaccine was 85% effective in preventing serious illness.
The FDA has said it will approve safe vaccines that are more than 50% effective. By the way, this requirement is not something unique, for example, a seasonal flu shot. works in only 40-60% of cases.
Specimen J&J can be transported in containers with temperatures from +2 to +8 degrees Celsius. By comparison, the Pfizer vaccine needs store exclusively in freezers cameras.
Ministry of Health and Human Services announced in August, which reached an agreement with Janssen, a pharmaceutical subsidiary of J&J, on the purchase of 100 million doses of vaccine. There is an option in the deal about the possibility to order an additional 200 million doses.