The Johnson & Johnson single dose vaccine protects against COVID-19, according to an analysis by U.S. regulators on Wednesday. The analysis sets the stage for a final decision on a new, easier-to-use injection to help tame the pandemic.
Food and Drug Administration scientists have confirmed that, in general, the vaccine is about 66% effective in preventing moderate to severe COVID-19. The agency also said that the J&J injection – which could help speed up vaccinations by requiring only one dose instead of two – is safe to use.
However, Johnson & Johnson expects fall far short of its commitment to deliver 10 million doses of its COVID-19 vaccine by the end of February, with less than 4 million ready for shipment. Johnson & Johnson’s disclosure of the deficit is the first public measure of exactly how far the pharmaceutical company has lagged behind in its production goals. Johnson & Johnson has promised to deliver another 25 million by the end of March.
“We will have 20 million doses of the vaccine to be made available by the end of March and we are prepared to dispatch, immediately after authorization for emergency use, almost 4 million doses of our vaccine”, Dr. Richard Nettles, Johnson & Johnson vice chairman of medical affairs for the Janssen subsidiary, said a hearing by the Chamber’s Energy and Commerce Committee on Tuesday.
This is just one step in the FDA’s assessment of a third vaccine option for the United States. On Friday, the agency’s independent consultants will debate whether the evidence is strong enough to recommend the long-awaited injection. Armed with this advice, the FDA is expected to make a final decision within a few days.
The vaccination campaign has been slower than expected, 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 the vaccine made by Pfizer or Moderna, injections that require two doses several weeks apart for full protection.
J&J tested its single-dose option on 44,000 people in the United States, Latin America and South Africa. As different mutant versions of the virus are circulating in different countries, the researchers analyzed the results geographically. J&J previously announced that the vaccine worked best in the U.S. – 72% effective against moderate to severe COVID-19, compared with 66% in Latin America and 57% in South Africa.
Still, in all countries, it was highly effective against the most severe symptoms, and the first results of the studies showed no hospitalizations or deaths from 28 days after vaccination.
While overall efficacy figures may suggest that the J&J candidate is not as strong as the two-dose competitors, all of the world’s COVID-19 vaccines have been tested differently, making comparisons almost impossible. While it is not surprising if one dose turns out to be a little weaker than two doses, policymakers will decide whether this is an acceptable trade-off to vaccinate more people more quickly.
J&J was on track to become the world’s first single-dose option by the beginning of this month, when Mexico announced it would use a single-dose version of China’s CanSino. This vaccine is made with technology similar to that of J&J, but initially it was developed as a two-dose option until the start of one-dose testing in the fall.
The rival vaccines Pfizer and Moderna used in the United States and in several other countries must be kept frozen, while the J&J injection can last for three months in the refrigerator, making handling easier. The AstraZeneca vaccine, widely used in Europe, Britain and Israel, is made in a similar way and also requires refrigeration, but takes two doses.
If the FDA authorizes the injection of J&J 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 expects 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 the J&J vaccine. Worldwide, the company plans to produce around one billion doses by the end of the year.
Alexander Tin contributed to this report.