FDA Says Johnson & Johnson One-Dose Vaccine Effective Against COVID-19

Foto: Johnson & Johnson vía AP
  • Johnson & Johnson vaccine. Single-dose vaccine protects against covid-19, the FDA reported in an analysis published today
  • The announcement sets the stage for a final decision on a new, easier-to-use vaccine to help control the pandemic.
  • However, the efficacy of the vaccine is approximately 66%, less than those of other pharmaceutical companies

Johnson & Johnson vaccine. Johnson & Johnson’s (J&J) one-dose vaccine protects against covid-19, according to an analysis released Wednesday by the U.S. Food and Drug Administration (FDA). The announcement sets the stage for a final decision on a new, easier-to-use vaccine to help control the pandemic.

FDA scientists confirmed that overall, the vaccine is approximately 66% effective in preventing moderate to severe COVID-19. The agency also said that the J&J injection could help speed up the population’s immunization process by requiring only one dose instead of two; Furthermore, it is safe to use.

That’s just one step in the FDA’s evaluation of a third vaccine option for the United States. On Friday, the agency’s independent advisers will debate whether the evidence is strong enough to recommend the long-awaited injection. With that advice, the FDA is expected to make a final decision in a few days.

The vaccination campaign has been slower than expected, with logistical problems and weather delays as obstacles, even as the country is in mourning after exceeding 500,000 deaths related to the virus. So far, about 44.5 million Americans have received at least one dose of the vaccine made by Pfizer or Moderna, and nearly 20 million have received the second dose necessary for full protection.

J&J tested its single-dose option on 44,000 people in the United States, Latin America, and South Africa. Different mutated versions of the virus are circulating in different countries, and the FDA analysis cautioned that it is unclear how well the vaccine works against each variant. But J&J previously announced that the vaccine worked better in the United States: 72% effective against moderate to severe COVID-19, compared with 66% in Latin America and 57% in South Africa.

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However, in all countries it was very effective against the most serious symptoms and the first results of the study showed no hospitalizations or deaths from 28 days after vaccination.

While overall effectiveness numbers may suggest that J & J’s candidate is not as strong as two-dose competitors, all of the world’s covid-19 vaccines have been tested differently, making comparisons nearly impossible. . While it wouldn’t be surprising if one dose turns out to be a bit weaker than two doses, lawmakers will decide if that’s an acceptable trade-off for more people to get vaccinated faster.

J&J was on its way to becoming the world’s first single-dose option until earlier this month, Mexico announced that it would use a single-dose version of CanSino from China. That vaccine is made with similar technology to J & J’s, but it was initially developed as a two-dose option until a one-dose trial began in the fall.

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Rival Pfizer and Moderna vaccines used in the United States in many other countries must be kept frozen, while the J&J injection can last three months in the refrigerator, making it easy to handle. AstraZeneca’s vaccine, widely used in Europe, Britain and Israel, is manufactured in a similar way and also requires refrigeration, but takes two doses.

If the FDA clears the J&J injection for use in the United States, it will not significantly increase vaccine supplies immediately. Only a few million doses are expected to be ready for shipment in the first week. But J&J told Congress this week that it expected to provide 20 million doses by the end of March and 100 million by the summer.

European regulators and the World Health Organization are also considering the J&J vaccine. Worldwide, the company aims to produce around 1 billion doses by the end of the year.

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