Post Sputnik V, Which Foreign Vaccines Could India Soon Authorise?
Amid the surging COVID-19 cases in India, calls for increased vaccination have become louder in the country.
While India grapples with the second and more severe wave since the COVID-19 pandemic began, calls for increased vaccination have become louder in the country, amid reports of shortage of vaccines in various states.
After a long wait, Russia's Sputnik V on Tuesday, 13 April, became the third vaccine and the first foreign one to get a green light for emergency use in India. Sputnik V’s approval comes after the Centre finally eased the path for vaccines from pharmaceutical companies that have been approved in the US, the UK and European countries, to seek approvals in India.
Meanwhile, the Centre said that it was fast-tracking Emergency Use Approvals (EUA) for foreign-produced COVID-19 vaccines that have been granted EUA in other countries. This is being done in order to expand the number of vaccines available for inoculation in the country.
Despite the world witnessing the development of many new vaccines, India has been much slower to authorise vaccines compared to the surge in cases and the overwhelmed health infrastructure.
However, this might change soon, as reports suggest that India might get more foreign vaccines. Earlier on, NITI Aayog's VK Paul indicated that India wants Pfizer, Moderna and Johnson & Johnson to seek a licence for their COVID-vaccines soon.
WHAT HAS CHANGED FOR THE GOVT?
While giving approval, the government has mandated the requirement of post-approval "parallel bridging clinical trial" rather than a "local clinical trial" as per the provisions prescribed under the Second Schedule of the New Drugs & Clinical Trials Rules, 2019.
A bridging clinical trial refers to a trial on a smaller local population, of a product manufactured and tested in a foreign country and its population.
With the new notification, the government has mandated a "parallel" bridging trial in which the first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunisation programmes within the country.
WHICH FOREIGN VACCINES WILL BE APPROVED AFTER THIS MOVE?
All the vaccines for COVID-19, which have been developed and are being manufactured in foreign countries and those that have been granted emergency approval for restricted use by USFDA, EMA, UK MHRA, PMDA Japan or the ones that are listed with WHO (Emergency Use Listing) may be granted emergency use approval in India.
1. Johnson & Johnson’s Jab
US pharma giant Johnson & Johnson on Friday, 9 April, confirmed that it is in talks with the Indian government to initiate a clinical bridging trial of its single-dose COVID-19 vaccine.
It has tied up with Hyderabad-based biopharmaceutical firm Biological E to expand manufacturing capabilities.
Johnson & Johnson has already tested the efficacy of the vaccine, which is reportedly 66 percent effective in preventing COVID-19. The vaccine was proven to be 72 percent effective against moderate and severe disease in the United States, the company said.
The vaccine, however, was found to be 85 percent effective in preventing severe disease across all regions studied, 28 days after vaccination in all adults. It has been approved for use in South Africa, Thailand, the USA and Europe.
Pfizer, which had developed the vaccine with BioNTech, was the first to apply for EUA in India, before the applications of Serum Institute of India (SII) and Bharat Biotech for their respective vaccines. It has, however, withdrawn its application for emergency use authorisation (EUA) of its COVID-19 vaccine in India, reports said on Friday, 5 February.
However, this may change considering that India has opened up its regulations recently to allow parallel clinical trials instead of a local bridging trial, which was where Pfizer had experienced its issues and had withdrawn.
Pfizer and BioNTech on 31 March had announced that the Phase 3 trial of their COVID-19 vaccine on adolescents of ages 12-15 in the US had shown 100 percent efficacy and “robust antibody responses”.
Pfizer has a very high efficacy of 95% against symptomatic infection.
US-based company, Moderna, is an mRNA vaccine. It is administered in two doses and must be 28 days apart. It needs to be stored between 2-8 degrees in a refrigerator.
The FDA review confirmed the earlier assessment that the Moderna vaccine had an efficacy rate of 94.1 percent across a trial of 30,000 people. Fever, headache and fatigue were some of the side effects reported, but these were common and not dangerous.
Unlike Pfizer, no serious allergic reactions have been observed so far in Moderna's vaccine. Bell's Palsy, a temporary facial paralysis, was observed in both vaccines in a few volunteers, though researchers say the number was not significant.
Covovax is a protein-based COVID-19 vaccine developed by Novavax, headquartered in the US, in collaboration with SII. Adar Poonawalla, SII CEO, announced on Saturday, 27 March, that they hope to launch Covovax by September 2021.
In August 2020, the two companies announced an agreement under which Novavax had given SII the licence to manufacture and supply one billion doses of the vaccine in low- and middle-income countries.
As per the new agreement, SII will also produce the antigen component of the vaccine. This will bring Novavax’s manufacturing capacity to over two billion doses by mid-2021.
Novavax's COVID-19 vaccine was 96.4 percent effective against the original strain of the virus in a Phase-3 trial in the UK, the company had said.
J&J’s Blood Clotting Issues
It is important to note that the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have recommended the Unites States to pause the use of Johnson & Johnson’s COVID vaccine over six reported cases of severe and rare blood clots in the country.
Around 6.8 million doses of the Johnson & Johnson’s vaccine have been administered in the United States so far, including the six rare cases.
According to a joint statement on Tuesday from Dr Anne Schuchat, Principal Deputy Director of the CDC, and Dr Peter Marks, Director of the FDA's Center for Biologics Evaluation and Research, all six cases occurred within 6 to 13 days of being vaccinated, among women between the ages of 18 and 48.
According to a federal health official, all federal health channels, including mass vaccination sites, community health centres and the likes, will stop administering the J&J vaccine for now.
The same was recommended for the states as well. However, since the states have their own allocation of the vaccine, pausing the vaccine will be at their discretion.
The pause is being initiated as the rare blood clot is not listed as a potential adverse side effect in the emergency use authorisation of the drug.
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