Johnson & Johnson’s single-dose vaccine protects against COVID-19, according to an analysis by US regulators Wednesday. The analysis provides the basis for a final decision on a new and easier-to-use shot to help tame the pandemic.
The Food and Drug Administration scientists have confirmed that, overall, the vaccine is about 66% effective in preventing moderate to severe COVID-19. The agency also said J & J’s injection – an injection that could speed up vaccinations by requiring just one dose instead of two – is safe to use.
Johnson & Johnson expects that fall far short of its commitment to deliver 10 million doses of its COVID-19 vaccine by the end of February, of which less than 4 million are ready for shipment. Johnson & Johnson’s disclosure of the deficit is the first public measure of exactly how far the pharmaceutical company is lagging behind its manufacturing goals. Johnson & Johnson promised to deliver an additional 25 million by the end of March.
“We will have 20 million doses of the vaccine available by the end of March, and we are ready to ship nearly 4 million doses of our vaccine immediately after emergency approval,” says Dr. Richard Nettles, Johnson & Johnson Subsidiary Janssen’s vice president of medical affairs told a House Energy & Commerce Committee hearing Tuesday.
That’s just one step in the FDA’s review of a third vaccine option for the US. On Friday, the agency’s independent advisers will debate whether the evidence is strong enough to recommend the long-awaited injection. Armed with that advice, the FDA is expected to make a final decision within days.
Vaccination coverage has been slower than hoped, hampered by logistical problems and weather delays, even as the country mourns more than 500,000 virus-related deaths. So far, about 65 million Americans have received at least one dose of vaccine from Pfizer or Moderna, injections that require two doses several weeks apart for complete protection.
J&J has tested the single-dose option on 44,000 people in the US, Latin America and South Africa. Because different mutated versions of the virus circulate in different countries, researchers geographically analyzed the results. J&J previously announced that the vaccine worked better in the US – 72% effective against moderate to severe COVID-19, compared to 66% in Latin America and 57% in South Africa.
Yet it was very effective against the most severe symptoms in every country, and early study results showed no hospitalizations or deaths from 28 days after vaccination.
While the overall effectiveness figures may suggest that the J&J 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 slightly weaker than two doses, policymakers will decide whether that is an acceptable trade-off 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 be using a single-dose version of CanSino from China. That vaccine is made with similar technology to J & J’s, but was initially developed as a two-dose option until a single-dose trial began in the fall.
The rival Pfizer and Moderna vaccines used in the US and many other countries need to be stored frozen, while the J&J shot can keep in the refrigerator for three months, making it easier to handle. The AstraZeneca vaccine, which is widely used in Europe, Great Britain and Israel, is made in the same way and also requires refrigeration, but it requires two doses.
If the FDA approves the J&J inclusion for use in the US, it will not significantly increase vaccine stock right away. Only a few million doses are expected to be ready for shipment in the first week. But J&J told Congress this week it is 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 J & J’s vaccine. Globally, the company aims to produce approximately one billion doses by the end of the year.
Alexander Tin contributed to this report.