Johnson & Johnson single dose vaccine protects against COVID-19, according to an analysis by US regulators on Wednesday. The analysis sets the stage for a final decision on a new and easier-to-use photograph to help tame the pandemic.
Food and Drug Administration scientists have confirmed that the vaccine is generally approximately 66% effective in preventing moderate to severe COVID-19. The agency also said that J & J’s shot – one that could help speed up vaccinations by requiring a single dose instead of two – is safe to use.
However, Johnson & Johnson is expected it remains very short of its commitment to deliver 10 million doses of COVID-19 vaccine by the end of February, with less than 4 million to be ready for shipment. The disclosure of the deficiency by Johnson & Johnson is the first public measure of exactly how far the drug company has lagged behind its production targets. Johnson & Johnson has promised to deliver another 25 million by the end of March.
“We will have 20 million doses of vaccine that will be available by the end of March and we are ready to deliver, immediately after the emergency use authorization, almost 4 million doses of vaccine,” Dr. Richard Nettles, Johnson & Johnson, vice president of medical affairs for the Janssen branch, said Tuesday at a hearing of the House Energy and Commerce Committee.
This is just a step in the FDA’s assessment of a third vaccination option for the US On Friday, the agency’s independent advisers will debate whether the evidence is strong enough to recommend the long-awaited shooting. Armed with this advice, the FDA is expected to make a final decision in a few days.
The vaccination effort has been slower than expected, hampered by logistical problems and weather delays, even as the country mourns more than 500,000 virus-related deaths. To date, approximately 65 million Americans have received at least one dose of vaccine made by Pfizer or Moderna, vaccines that require two doses a few weeks apart for complete protection.
J&J tested its single dose option on 44,000 people in the US, Latin America and South Africa. Because different mutant versions of the virus circulate in different countries, the researchers analyzed the results geographically. J&J previously announced that the vaccine works better in the US – 72% effective against moderate to severe COVID-19, compared to 66% in Latin America and 57% in South Africa.
However, in each country it was extremely effective against the worst symptoms, and the results of early studies showed no hospitalizations or deaths since 28 days after vaccination.
While overall efficacy figures may suggest that the J&J candidate is not as strong as its two-dose competitors, all COVID-19 vaccines in the world have been tested differently, making comparisons almost impossible. While it would not be surprising if one dose turns out to be slightly lower than two doses, policy makers will decide whether this is an acceptable compromise to vaccinate more people faster.
J&J was set to become the world’s first single-dose option by the beginning of this month, with Mexico announcing that it will use a single-dose version of China’s CanSino. The vaccine is made with a technology similar to J&J, but was initially developed as a two-dose option until a single-dose test was started in the fall.
Rival Pfizer and Moderna vaccines used in the US and many other countries must be kept frozen, while the J&J shot can last three months in the refrigerator, making it easier to handle. The AstraZeneca vaccine, widely used in Europe, the United Kingdom and Israel, is similarly manufactured and also requires refrigeration, but takes two doses.
If the FDA eliminates the J&J vaccine for use in the United States, it will not significantly increase vaccine consumption immediately. Only a few million doses are expected to be ready for delivery 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 summer.
European regulators and the World Health Organization are also considering the J&V vaccine. The company aims to produce around one billion doses worldwide by the end of the year.
Alexander Tin contributed to this report.