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Johnson & Johnson’s single-dose vaccine protects against COVID-19[female[feminine, according to an analysis of US regulators Wednesday. The analysis sets the stage for a final decision on a new, easier-to-use vaccine to help tame the pandemic.
Food and Drug Administration scientists have confirmed that overall, the vaccine is around 66% effective in preventing moderate to severe COVID-19. The agency also said J & J’s vaccine – which could help speed up vaccinations by requiring just one dose instead of two – is safe to use.
However, Johnson & Johnson expects fall away of its commitment to deliver 10 million doses of its COVID-19 vaccine by the end of February, of which less than 4 million will be ready to ship. Johnson & Johnson’s disclosure of the deficit is the first public measure of how exactly the drug company is behind its production targets. Johnson & Johnson has pledged to deliver an additional $ 25million by the end of March.
“We will have 20 million doses of vaccine available by the end of March and we are ready to ship, upon approval for emergency use, nearly 4 million doses of our vaccine”, Dr Richard Nettles, Johnson & Johnson The Janssen subsidiary’s vice president of medical affairs said Tuesday during a hearing of the home’s energy and commerce committee.
This is only one step in the FDA’s assessment of a third vaccine option for the United States. The agency’s independent advisers will debate whether the evidence is strong enough to recommend the long-awaited vaccine on Friday. Based on this advice, the FDA should make a final decision within days.
The vaccination campaign has been slower than expected, hampered by logistical problems and weather delays even as the country mourns over 500,000 virus-related deaths. So far, about 65 million Americans have received at least one dose of vaccine manufactured by Pfizer or Moderna, injections that require two doses several weeks apart for full protection.
J&J has tested its single-dose option in 44,000 people in the United States, Latin America and South Africa. Because different mutated versions of the virus are circulating in different countries, the researchers analyzed the results geographically. J&J previously reported that the vaccine worked best in the United States – 72% effective against moderate to severe COVID-19, compared to 66% in Latin America and 57% in South Africa.
Yet in all countries it was very effective against the most severe symptoms, and initial study results showed no hospitalization or death from 28 days after vaccination.
While the overall efficacy figures may suggest that candidate J&J is not as potent as the two-dose competitors, all of the world’s COVID-19 vaccines have been tested differently, making comparisons nearly impossible. While it’s no surprise that one dose turns out to be a little lower than two doses, policymakers will decide if this is an acceptable compromise to get more people vaccinated faster.
J&J was on track to become the world’s first single-dose option until earlier this month Mexico announced it would use a single-dose version of CanSino in China. This vaccine is made with similar technology to J&J, but was initially developed as a two-dose option until a single-dose test began in the fall.
Rival vaccines Pfizer and Moderna used in the United States and many other countries must be stored frozen, while the J&J vaccine can last for three months in the refrigerator, making it easier to handle. AstraZeneca’s vaccine, widely used in Europe, Britain and Israel, is made similarly and also requires refrigeration, but takes two doses.
If the FDA clears the J&J vaccine for use in the United States, it won’t dramatically increase vaccine stocks right away. Only a few million doses are expected to be ready to ship in the first week. But J&J told Congress this week that it plans to deliver 20 million doses by the end of March and 100 million by the summer.
European regulators and the World Health Organization are also considering J & J’s vaccine. Globally, the company aims to produce around one billion doses by the end of the year.
Alexander Tin contributed to this report.
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