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The pharmaceutical company, “Johnson & Johnson”, announced that it had filed an application with US health authorities on Thursday for an emergency license for its Covid-19 vaccine.
And if it gets the green light from the US Food and Drug Administration, this vaccine will be the third authorized in the United States, after the Pfizer-Bionic and Moderna vaccines.
This vaccine is particularly needed because it has two important logistical advantages, as it can be stored at normal refrigerant temperatures, which will greatly facilitate its distribution, and it is also given to people with a single dose.
“We are ready to begin deliveries” as soon as approval is granted, said Paul Stoffels, Scientific Director of Johnson & Johnson, describing the request submitted Thursday as “a critical step”.
Johnson & Johnson has provided the United States Food and Drug Administration, the country’s main federal public health agency, with what is known in the United States as an emergency use permit.
The FDA must now establish a vaccine advisory committee that will issue an opinion after reviewing clinical trial data. He will be responsible for determining whether the benefits of the vaccine outweigh the risks of its use.
This step took about three weeks for the Pfizer / Bionic Moderna vaccine, but it may be faster this time around. The vaccine should then receive the green light, possibly after consulting the advisory committee.
66% efficient
Johnson & Johnson has pledged to ship 100 million doses of its vaccine to the United States by the end of June.
And the pharmaceutical giant announced at the end of last week the first results of its clinical trials which carried out approximately 44,000 people in eight countries.
The company said the vaccine was generally 66% effective, while the effectiveness increased to 85% in preventing severe symptoms of the virus.
But these results also raised concerns: the vaccine was more effective in the United States (72%) than in South Africa (57%), as a mutated version of the virus appeared in that country and became the dominant one. for a great degree.
Experts see it as an indication that any future mutated copy could end up bypassing the immune defenses developed by current vaccines. This is another reason, they believe, to speed up vaccination campaigns.
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