Novavax’s COVID-19 vaccine 90% effective, may be India’s 4th shot

Vaccine-maker Novavax has claimed that its coronavirus vaccine was over 90 per cent effective on COVID-19 and its variants, after conducting a large-scale study in the US and Mexico.

In a press release issued on Monday, the company stated that the vaccine provides 90.4 per cent overall efficacy while giving 100 per cent protection against moderate and severe diseases. It has 93 per efficacy against predominantly circulating variants of concern and variants of interest while having 91 per cent efficacy in high-risk populations.

The pharmaceutical company has said that it would apply for regulatory approval in the US, Europe and other countries by the third quarter of 2021 as well as produce up to 100 million doses of the vaccine per month. While stating that 1.1 billion doses have been committed to Covax, company’s chief executive Stanley Erck said that a bulk of the first doses will be shipped to low and middle-income countries.

The study involving 29,960 participants above 18 years, across 199 places in the US and Mexico examined the efficacy, safety and immunogenicity of the vaccine. Around two-thirds of the participants received two doses of the vaccine, three weeks apart, while the rest received the placebo. While there were 77 cases of COVID-19 in the group that received the vaccine, the same was 14 in the placebo group.

The vaccine is also said to be effective against COVID variants including that found in the UK. While there were no reports of blood clotting or heart ailments, side effects like mild tenderness and pain where the injection is administered were reported.

The results of the study will be soon published in a medical journal.

It is said that the results of the trial equal that of Pfizer and Moderna vaccines and are better than the jabs by Johnson and Johnson.

Even though the regulatory approval for the vaccine may be delayed in the US, considering the country’s existing line-up of vaccines and the fact that it has already inoculated half of its population, the shots will come to the rescue of low and middle-income countries which have been facing hiccups in vaccination.

In India, the vaccine will be manufactured under the name Covax by Serum Institute of India.

Erk told New York Times that the firm has already applied for emergency use approvals in the UK, EU, Korea and India.

Reports say the vaccine is in advanced stages of “observer-blinded, randomized, active-controlled” bridging trials in India which involves 1,600 volunteers above 18 years across 15 centres.

“The results are very encouraging and we are looking forward to the vaccine. We are already engaged with SII for supplies and the company is doing trials with ICMR. It is a very promising vaccine candidate and we are hopeful that they will be able to submit data in India for regulatory approvals very soon,” an Indian official told TOI.

Reports said India may produce 20 crore shots of the vaccine between September and December this year. The vaccine is being considered to be used as a booster shot for already vaccinated people.

The Indian government may release the first lot of the vaccine by August-September if the regulatory approvals are in place. According to TOI, SII too had plans to apply for expedited authorization under the government’s revised norms if the vaccine was approved for emergency use in UK or Europe.

The vaccine which can be easily stored in standard refrigerators, is expected to cost ₹1,114 per dose.

It may be the fourth vaccine that India may introduce. While India’s indigenous vaccine Covaxin has an efficacy rate of 78 per cent, Covishield can have an efficacy rate up t0 90 per cent when people are first given half a dose and then a full dose. Russian vaccine Sputnik V has an efficacy of 92 per cent.