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The US looks set to get a third Covid-19 vaccine for emergency use, as the Johnson and Johnson (J&J) candidate comes up for review on Friday.
The US Food and Drug Administration’s advisory committee review of the J&J vaccine is being watched with interest, also because it is the only one-dose vaccine as of now. In fact, the J&J vaccine received a shot in the arm with the FDA finding the vaccine safe and effective, ahead of the advisory panel meeting, foreign media reported.
FDA says single-dose shot from J&J prevents severe Covid-19
A one-dose vaccine also becomes critical as shortages are reported out of different countries, leading to Governments delaying the roll-out of the second dose. India’s Biological E has an alliance with J&J to produce this vaccine.
The other vaccines that have received Emergency Use Authorisation in the US are Pfizer-BioNTech and Moderna’s m-RNA vaccines. Both are two-dose vaccines. The AstraZeneca-OxfordUniversity vaccine, recently listed for emergency use by the World Health Organization (WHO), the second after Pfizer, is also a two-dose vaccine.
Sanofi to help J&J manufacture its Covid-19 vaccine in Europe
Phase III trials
In a communication late last month, J&J had said its investigational single-dose Covid-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints. And the topline safety and efficacy data from its advanced Phase III trials was based on 43,783 participants.
“Among all participants from different geographies and including those infected with an emerging viral variant, Janssen’s Covid-19 vaccine candidate was 66 per cent effective overall in preventing moderate to severe Covid-19, 28 days after vaccination,” the company said. Further, it added, “the level of protection against moderate to severe Covid-19 infection was 72 per cent in the United States, 66 per cent in Latin America and 57 per cent in South Africa, 28 days post-vaccination.”
Forty-five per cent of participants in the trial were female, and the rest were male, J&J said of the trial that was diverse in its participation. Interestingly, “forty-one per cent of participants in the study had co-morbidities associated with an increased risk for progression to severe Covid-19 (overall 41 per cent), obesity (28.5 per cent), type 2 diabetes (7.3 per cent), hypertension (10.3 per cent), HIV (2.8 per cent); also other immunocompromised participants were in the study,” it added.
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