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2 new vaccines, Covid pill approved for use

By, New Delhi
Dec 28, 2021 11:23 PM IST

The DCGI on Tuesday approved Covovax and Corbevax vaccines, as well as US pharma company Merck’s anti-viral drug, molnupiravir.

New Delhi: India’s drugs regulator on Tuesday approved two more coronavirus vaccines, and a new pill to treat people with mild-to-moderate Covid-19, adding to the country’s tools to fight the pandemic at a time of growing worries that the new Omicron variant of the Sars-CoV-2 may lead to a new wave.

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Representative Image

Both the doses – Covovax and Corbevax – approved on Tuesday are being produced in India, making it likely for supplies to commence soon, and giving the country more options for booster doses.

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“Congratulations India. Further strengthening the fight against COVID-19, CDSCO, @MoHFW_INDIA has given 3 approvals in a single day for: CORBEVAX vaccine, COVOVAX vaccine, anti-viral drug Molnupiravir -- for restricted use in emergency situation,” said Union health minister Mansukh Mandaviya in a tweet.

The coronavirus vaccination drive is being expanded to cover children of age 15 and above, and allow additional doses for fully vaccinated health care and front line workers, as well as people above the age of 60 with certain underlying health conditions.

“There are adequate vaccine supplies now as we already have some 200 million balanced and unutilised doses with the states currently, and 200 million more doses are expected by February end. Also, over and above, we have a deal for 300 million Corbevax doses for which advance payment has already been made. Therefore, there is no immediate need for procuring more vaccine doses, and the current supplies will see us covering the major chunk of beneficiaries even for the precaution dose,” said a senior government official aware of the matter, on condition of anonymity.

With the two new approvals, India has eight Covid vaccines for emergency use including Serum Institute’s (SII) Covishield, Bharat Biotech’s Covaxin, Zydus’s ZyCoV-D, Russia-made Sputnik V, and the doses made by Moderna and Johnson & Johnson. To be sure, of these only Covishied, Covaxin and Sputnik are being administered so far.

Covovax is also being made by SII, which has a licence to produce two billion doses. The vaccine has shown a 90% efficacy rate in preventing symptomatic infection, and SII began stockpiling doses in June.

Corbevax is being made by Biological E as part of a partnership with Texas-based Baylor College of Medicine and Texas Children’s Hospital Center for Vaccine Development.

“The new vaccines that are getting added to the basket can be used later if and when booster doses are allowed, and also for export purposes as we have to also think globally because of the nature of pandemic where every single person has to be safe for the world to be safe,” added a second government official, asking not to be named.

On boosters, studies from many countries suggest mixing boosters could lead to better protection.

Covovax’s developer, US-based Novavax, has a deal with the World Health Organization-led Covax Facility for its distribution to low- and middle-income countries.

Biological E announced on December 3 that the company has applied for the emergency use authorisation to the central drugs standard control organisation (CDSCO), which took the decision on Tuesday. Though no trial data is available yet, the company said comparisons of antibody response with other vaccine makers showed it had over 90% efficacy against the original variant and over 80% protection against Delta variant.

“BioE has 150 million doses ready now, and will be making 100 million per month,” said Peter Hotez, the dean of Texas Children’s Hospital and professor at the Baylor College of Medicine. “We technology transferred our vaccine and helped in its co-development with BioE with no patent and no strings attached. As a result it should be the least expensive Covid vaccine available yet,” he said, adding that the authorisation was based “on superiority studies to another well-established Covid-19 vaccine”.

In June this year, the central government said it finalised arrangements with Biological E to reserve 300 million Corbevax doses and made an advance payment of 1,500 crore.

The vaccine is administered through the intramuscular route with two dose schedule 28 days apart. The vaccine needs to be stored in refrigerator temperatures at 2˚C to 8˚C.

In August last year, SII tied up with the US biotechnology company Novavax to locally test and manufacture its recombinant nanoparticle protein-based Covid-19 vaccine, NVX-CoV2373. The World Health Organisation on December 17 granted emergency use listing to Novavax. SII is producing it under the brand name Covovax.

SII locally conducted phase 2/3 immuno bridging clinical studies for comparing safety and immunogenicity of Covovax and Novavax vaccine.

The vaccine is also administered through the intramuscular route but with 21-day gap between two doses. The vaccine is stored at 2˚C to 8˚C.

The company issued a release confirming the approval by the CDSCO.

“The approval of COVOVAX by DCGI is a significant milestone in strengthening our immunisation efforts across India and LMICs,” said Adar Poonawalla, CEO, SII.

US pharma company Merck’s anti-viral drug, molnupiravir, which inhibits Sars-CoV-2 replication also received the approval.

The drug was approved in the UK and US earlier this month and is used for treatment of mild to moderate Covid-19 in adults, with a course lasting five days.

“CDSCO received 22 applications for manufacture and market of the drug in the country, of which eight including five applicants of a consortium (total 13) have submitted their clinical trial report interim or complete report. Considering the emergency and unmet medical need in Covid-19, the Subject Expert Committee recommended for grant of permission to manufacture and market..,” said health ministry in a statement.

Merck released the patent for the drug to the UN-led Medicines Patent Pool, allowing generics makers to make the drug.

In India, molnupiravir is approved as 200mg capsule with recommended dose of 800 mg twice daily for five days for the treatment of adults with Covid-19 who have their oxygen saturation above 93%, and who have high risk of progression of the disease including hospitalisation or death subject to various conditions.

“The approval supports patent access to Molnupiravir in India and for more than 100 low-and middle-income countries… We are pleased to work with our voluntary licensing and manufacturing (partners) in expanding access for Molnupiravir..,” said Rehan A Khan, managing director, MSD-India region. MSD is a trade name of Merck & Co, Inc, with headquarters in Kenilworth, US.

Experts say it is good to have more options open in our fight against Covid-19

“The more choice we have better it is; and as far as vaccines is concerned, indigenous vaccines will surely have an edge over other vaccines in terms of storage and transportation. We have now five vaccines being manufactured in India, and three are WHO approved, which is great. More data will emerge subsequently to tell us which vaccine will work better in what population group,” said Dr Sandeep Budhiraja, group medical director, Max Healthcare, and senior director, Institute of Internal Medicine.

As for molnupiravir, Dr Budhiraja, said, “The drug initially showed very high results but eventually came down to 30% efficacy, which may not be much but at least one drug is there specifically to manage Sars-CoV-2. We will have to select right set of patients and time it well for better results because the percentage of hospitalization may seem low, but in absolute numbers it will be big for us.”

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  • ABOUT THE AUTHOR
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    Rhythma Kaul works as an assistant editor at Hindustan Times. She covers health and related topics, including ministry of health and family welfare, government of India.

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