NEW DELHI :
In another potential boost to availability of robust covid-19 vaccines in India, Novavax early Friday announced its interim phase-3 results showing that its protein subunit jabs have an efficacy of 89.3% against the novel coronavirus.
More importantly, the efficacy results of the vaccine come from a trial in UK and South Africa, where two more transmissible strains are more prevalent, indicating that the vaccine provides protection against them.
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“NVX-CoV2373 is the first vaccine to demonstrate not only high clinical efficacy against COVID-19 but also significant clinical efficacy against both the rapidly emerging UK and South Africa variants,” Novavax president and chief executive officer Stanley C. Erck said in a statement.
In India, Serum Institute will be manufacturing around 1 billion doses of the vaccine under the local brand Covovax, with half of them expected to be reserved for India. The company will start manufacturing the vaccines from March, chief executive officer Adar Poonawalla has earlier said.
Novavax’s efficacy results from the phase 3 trial in UK is based on 62 covid-19 cases more than 15,000 participants between 18-84 years of age. Of the total cases, 56 were observed in the placebo group and six cases in the vaccine group, resulting in a point estimate of 89.3%.
Of the 62 cases, 32 were infected with the new UK strain. An analysis of 56 of these cases showed that the vaccine was 95.6% against the original coronavirus strain and 85.6% against the UK variant strain, the company said.
“The efficacy shown against the emerging variants is also extremely encouraging. This is an incredible achievement that will ensure we can protect individuals in the UK and the rest of the world from this virus,” said UK Vaccine Taskforce chairperson Clive Dix was quoted as saying in the statement.
In South Africa, the company conducted a phase 2b trial of over 4,400 participants with cases being counted from September through mid-January. At last count, the researchers had 44 cases, and genetic sequencing of some of the samples showed that 92.6% of them were infected with the new South Africa variant of the virus. The efficacy rate in the South Africa arm of the trial was 60%.
“The 60% reduced risk against COVID-19 illness in vaccinated individuals in South Africans underscores the value of this vaccine to prevent illness from the highly worrisome variant currently circulating in South Africa, and which is spreading globally,” Shabir Maddi, executive director of the Vaccines and Infectious Diseases Analytics Research Unit (VIDA) and principal investigator in the Novavax vaccine trial in South Africa, said in the statement.
The company said that additional analysis on both trials is ongoing and the results will be shared via non-peer reviewed pre-print portals as well as submitted to a peer-reviewed journal for publication.
Novavax is also conducting a trial of 30,000 participants in the US and Mexico, and has so far enrolled over 16,000 participants and expects to complete it targeted enrollment in the first half of February.
The company initiated a rolling submission to the UK’s regulatory agency, the Medicines and Healthcare products Regulatory Agency (MHRA), in mid-January.
An approval in the UK could provide a boost to its emergency licensure in India. However, Serum Institute of India, which is contract manufacturing the vaccine under its brand Covovax and planning to conduct a bridging study, has not yet received a clearance from the Indian regulator’s subject expert committee to conduct a trial.
In a meeting on 19 January, the company was asked to “submit revised clinical trial protocol before the committee for further deliberation”, as per the minutes of the meeting.
