NEW DELHI: The Covid vaccine by the US-based Novavax has shown the efficacy of over 90% in preventing infection and 100% efficacy against moderate to severe disease, the company claimed on Monday while announcing results from its phase 3 clinical trials.
These results assume significance for India too as the Serum Institute of India is a manufacturing partner for the vaccine and government authorities have earlier indicated that about 20 crore doses of the vaccine may be available in the country between August-December.
Novavax said in a statement that its recombinant nanoparticle protein-based Covid19 vaccine was tested in nearly 30,000 volunteers between January-April in the US and Mexico and included nearly 44% non-white participants.
The two doses of the vaccine are administered 21 days apart and its efficacy results are being compared to the vaccines by Pfizer and Moderna, as the phase 3 trials of this vaccine conducted later meant that it was pitted against more aggressive variants of Covid virus.
Efficacy endpoints were accrued from January 25 through April 30— a time when the Alpha (B.1.1.7) variant, first identified in the UK, became the predominant strain in the US while other strains, including Variants of Interest and Variants of Concern, were also on the rise.
The firm said that a total of 77 Covid cases were observed, 63 in the placebo group and 14 in the vaccine group while all cases observed in the vaccine group were mild as defined by the trial protocol.
In the late-stage trials, Novavax sequenced 70% of all the coronaviruses that caused illness. In more than half of the sequenced cases, the culprit was the Alpha variant, which accounted for 70% of US infections by the time Novavax’s trial closed. But the statement released on Monday did not provide specific efficacy data against Alpha or any other variant.
Ten moderate cases and four severe cases were observed, all in the placebo group, yielding a vaccine efficacy of 100% against moderate or severe disease, claimed Novavax adding that it will seek regulatory approvals in the US in the next quarter.
Upon regulatory approvals, the company plans to reach a manufacturing capacity of 10 crore doses per month by the end of the third quarter and 15 crore doses per month by the end of 2021.
SII, which is the production partner for the vaccine, will launch its own version of the vaccine in the country and has currently undertaken a bridging clinical trial on about 1600 healthy volunteers in India.
The company has, however, also hinted that a ban by the US on imports of raw material required for vaccine production may delay and hamper the manufacturing of this vaccine locally.