“Covaxin” May get WHO Approval Soon

Manas Dasgupta

NEW DELHI, June 17: As Bharat Biotech’s “Covaxin” moved an inch closer to get approval of the World Health Organisation, India’s other vaccine manufacturer the Serum Institute of India (SII) announced its plans to start clinical trials of the Novavax vaccine against Covid-19 for children in July.

The SII also hopes to introduce Covavax, which is a version of US firm Novavax’s Covid-19 vaccine candidate, in the country by September, media reports said quoting SII sources.

India’s vaccine against COVID-19 Covaxin has been granted a pre-submission meeting for its emergency use listing scheduled for June 23 by the WHO.

“The meeting on the vaccine developed by Bharat Biotech is planned for June 23,” a WHO document on the status of COVID-19 vaccines within EUL/PQ evaluation process and last updated on Thursday said.

Bharat Biotech, which in association with Indian Council for Medical Research (ICMR) has developed the whole-virion inactivated vaccine, last month said the WHO approval was expected in the July-September quarter. The WHO had then said the application was submitted on April 19 and more information was needed. A pre-submission meeting was scheduled in May-June, the U.N. agency had said.

A WHO approval will come as a big boost for Covaxin and expected to pave the way for all those inoculated with it to travel to many countries. “We are also looking forward to WHO’s approval for India’s indigenous vaccine manufactured by Bharat Biotech,” Foreign Secretary Harsh Vardhan Shringla had told WHO’s South-East Asia Regional Health Partners’ Forum on COVID-19 earlier this month.

While the United States government has said it would not introduce digital vaccine passports by federal mandate, a growing number of businesses — from cruise lines to sports venues — say they will require proof of vaccinations for entry or services. Hundreds of digital health pass initiatives are scrambling to launch apps that provide a verified electronic record of immunizations and negative Covid test results to streamline the process. But any such “vaccine passport” would be applicable only for the vaccine approved by the WHO. For the Indian users, while the SII Manufactured “Covishield” has received the WHO approval, “Covaxin” is yet to get the nod and those who have been vaccinated by “Covaxin” could find it difficult to enter the European countries despite having taken double doses of vaccine.

Though on Thursday India recorded a marginally higher number of daily new cases compared to the previous day, indications were clear that the worst of the second phase is over. A single day rise of 67,208 new coronavirus infections were recorded taking India’s total tally of COVID-19 cases to 2,97,00,313, while the active cases declined to 8,26,740, the lowest after 71 days, according to the Union Health Ministry data updated on Thursday. India had recorded about 62,000 cases on Wednesday.

The COVID-19 death toll climbed to 3,81,903 with 2,330 fresh fatalities, the data updated at 8 am showed The active cases declined to 8,26,740 comprising 2.78 per cent of the total infections, while the national COVID-19 recovery rate has improved to 95.93 per cent. A net decline of 38,692 cases has been recorded in the COVID-19 caseload in a span of 24 hours.

The daily positivity rate was recorded 3.48 per cent . It has been less than 5 per cent for the 10th consecutive day, the ministry said, adding the weekly positivity rate has declined to 3.99 per cent.

Recoveries continue to outnumber daily new cases for the 35th consecutive day. The number of people who have recuperated from the disease surged to 2,84,91,670, while the case fatality rate has increased to 1.29 per cent, the data stated.

Novavax Inc, which has a vaccine manufacturing agreement with SII, had said on Monday that its Covid-19 vaccine candidate was highly effective with 90.4 per cent efficacy overall and also showed high efficacy against predominantly circulating variants. The vaccine demonstrated 93 per cent efficacy against predominantly circulating variants of concern and variants of interest, Novavax said.

Novavax said in a statement that the vaccine candidate, ‘NVX-CoV2373’, demonstrated 100 per cent protection against moderate and severe disease, 90.4 per cent efficacy overall and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial.

The study enrolled 29,960 participants across 119 sites in the US and Mexico to evaluate efficacy, safety and immunogenicity of the vaccine, it added.

On Tuesday, the government said the efficacy data of Novavax vaccine against Covid-19 is promising and encouraging and its clinical trials were in an advanced stage of completion in India. NITI Aayog member (health) VK Paul said the data available in the public domain also indicated the vaccine was safe and highly effective.

“What we are learning from the available data is that this vaccine is very safe and it is highly effective but what makes this vaccine relevant for today is the fact that this vaccine will be produced in India by Serum Institute,” he said during a press conference.

Paul said there was preparatory work already accomplished by the SII and that they were also conducting a bridging trial which was in advanced stages of completion.

“I am also hoping that they will also start trials on children which is of special interest to all of us. The pace of vaccination should see a renewed energy from next week onwards when we will realign our efforts, state efforts and effective scale-up at ground level are expected,” he added.

The average daily vaccination rate in the first 10 days of June was relatively higher than the levels recorded initially in May after India opened up inoculation for all adults.

From June 1 to 10, on an average three million doses were administered daily. At the current rate, by July 31, around 403 million doses can be administered, though it would still about 100 million doses lower than the target, the official sources admitted.