Union Health Minister Mansukh Mandaviya on Tuesday said that the Central Drugs Standard Control Organisation (CDSCO) has approved the Serum Institute of India’s Covid-19 vaccine Covovax, Biological E’s jab Corbevax and anti-Covid pill Molnupiravir for “restricted use in emergency situation”. The announcement came even as Delhi sounded a “Yellow alert” with the city reporting 496 positive Covid-19 cases and one death in the last 24 hours, and active cases jumping to 1,612, Schools, cinemas, gyms would be shut with immediate effect, among other restrictions, announced Delhi Chief Minister Arvind Kejriwal.
The Centre also told states and Union territories on Tuesday that people aged 60 years and above with co-morbidity will not be required to produce or submit any certificate from a doctor at the time of administration of “precaution dose” of Covid-19 vaccine. Such persons are expected to obtain the advice of their doctor before deciding to avail of the precaution dose or third dose. In a letter to states and UTs, Union Health Secretary Rajesh Bhushan said personnel to be deployed in election duty in the poll-bound states will be included in the category of frontline workers. Eligibility of such beneficiaries for the precaution dose will be based on the date of administration of 2nd dose as recorded in the Co-WIN system—completion of nine months i.e. 39 weeks from the date of administration of second dose—Bhushan said.
The Union Health Ministry also said on Tuesday that Covid-19 vaccination for those between 15 to 18 years can be taken without appointments. “Appointments can be booked online or onsite (walk-in). Services in the on-site (walk-in) mode will be available subject to the availability of vaccination slots,” the Union Health Ministry said.
Taking to Twitter, Mandaviya said in a series of tweets, “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 an emergency situation.” Further elaborating on CORBEVAX vaccine, the Minister said that it is the first indigenously developed RBD protein sub-unit vaccine against Covid-19. “CORBEVAX vaccine is India’s 1st indigenously developed RBD protein sub-unit vaccine against #COVID19, Made by Hyderabad-based firm Biological-E. It’s a hat-trick! It’s now 3rd vaccine developed in India!” the Minister tweeted. “The Nanoparticle Vaccine, COVOVAX, will be manufactured by Pune-based firm Serum Institute of India,” Mandaviya further added in the tweet.
The Minister informed that the antiviral drug, Molnupiravir will be used for emergency situation for the treatment of adult patients with Covid-19 and who have a “high risk of progression of the disease”.
“Molnupiravir, an antiviral drug, will now be manufactured in the country by 13 companies for restricted use under emergency situation for treatment of adult patients with COVID-19 and who have a high risk of progression of the disease,” he tweeted.
The Minister said that all these approvals will further strengthen the global fight against the pandemic adding that India’s Pharma Industries are asset for the entire world.
“PM @NarendraModi Ji has led the battle against #COVID19 from the front. All these approvals will further strengthen the global fight against the pandemic. Our Pharma Industries are asset for the entire world,” he tweeted. Earlier, India had developed Covaxin, the first indigenously developed Covid-19 vaccine which was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) National Institute of Virology.
After the Centre clearing two new vaccines and one anti-viral drug for emergency use on Tuesday, vaccine manufacturers welcomed the announcement and said that this would support the patients across India. Serum Institute of India on Tuesday expressed gratitude to the Union Health Ministry for granting Emergency Use Authorization for its Covid-19 vaccine Covovax. “Thank you, Hon. @mansukhmandviya for granting Emergency Use Authorization for COVOVAX in India. This is a highly effective vaccine and is a big step in India’s fight against Covid-19,” tweeted the SII.
The manufacturing company of CORBEVAX, Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company, said in a release that it is a “recombinant protein sub-unit” vaccine, developed from a component of the spike protein on the virus’s surface, which helps the body build the immune response against the virus. The company said the vaccine has the Receptor Binding Domain (RBD) protein as an antigen, and also an optimum adjuvant consisting of Dynavax (DVAX) CpG 1018 and alum. “Biological E. Limited’s CORBEVAX has completed two Phase III clinical trials involving more than 3000 subjects between the ages of 18 and 80 at 33 study sites across India. The vaccine was found to be safe, well-tolerated and immunogenic,” said the release.
“CORBEVAX nAb GMT against the Delta strain indicates vaccine effectiveness of more than 80 per cent for the prevention of symptomatic infections based on published studies,” it added.
Biological E. Limited plans to complete production at a rate of 75 million doses per month, anticipating 100 plus million doses per month from February 2022. These capacities will enable the Hyderabad-based company to deliver 300 million doses as promised to the Government of India. Soon, the company plans to deliver more than one billion additional doses globally.
Meanwhile, Cipla, one of the 13 manufacturing companies of the anti-viral drug Molnupiravir, on Tuesday said in a press release,” Cipla plans to launch Molnupiravir under the brand name Cipmolnu. “Cipla will soon make Cipmolnu 200mg capsules available at all leading pharmacies and Covid treatment centres across the country. The company has adequate manufacturing capacities and a solid distribution mechanism in place to ensure speedy access to this effective treatment pan India,” it said.
Molnupiravir is an oral antiviral that inhibits the replication of multiple RNA viruses including SARS-CoV-2. The drug is used for the treatment of non-hospitalized patients with confirmed Covid-19 globally. Managing Director, MSD India Region, Rehan A. Khan welcomed the decision by the government and said that the approval would support the patients across India.
Amid the surging Covid-19 cases following the emergence of Omicron variant in the national capital and positivity rate above 0.50 per cent for two consecutive days, restrictions have been imposed under “Yellow alert” as per the Graded Response Action Plan (GRAP) under which Delhi Metro, restaurants, bars will operate at 50% capacity. As per the restrictions, a night curfew has been imposed between 10 pm-5 am in the national capital. Cinema halls, schools, spas, gyms, multiplexes, banquet halls, auditoriums and sports complexes have been closed with immediate effect. Delhi Chief Minister Arvind Kejriwal on Tuesday announced the implementation of Level-I (Yellow alert) of the Graded Response Action Plan in New Delhi. Addressing after the review meeting, Kejriwal said, “Corona cases are increasing for a few days, but the symptoms are mild in the patients, there is no need to panic, GRAP was made a few days ago so that it could be known scientifically that if there is this level of corona then the things will be closed. It was written in it that if the infection rate is more than 0.5 per cent, then the yellow level will be applicable.”
Meanwhile, a total of 6,358 new Covid-19 cases were reported in India in the last 24 hours, taking the active caseload in the country to 75,456, informed the Ministry of Health and Family Welfare on Tuesday. Maharashtra reported 2,172 new Covid-19 cases during the last 24 hours, said the state health department on Tuesday. However, no new cases of Omicron variant of the virus were reported in the state during the last 24 hours.
According to the Health Ministry, 653 cases of Omicron variant of coronavirus have been reported in the country so far. Out of this, Maharashtra topped the list with 167 cases followed by Delhi with 165 cases, Kerala with 57 cases and Telangana has confirmed 55 cases. The active cases account for less than 1 per cent of total cases and is currently at 0.22 per cent, which is the lowest since March 2020. With the recovery of 6,450 patients in the last 24 hours, the cumulative tally of recovered patients since the beginning of the pandemic has increased to 3,42,43,945. The current recovery rate at 98.40% which is the highest since the beginning of the pandemic. With the administration of 72.87 lakh vaccine doses in the last 24 hours, India’s vaccination coverage has exceeded 142.47 crore crore (1,42,46,81,736) as per provisional reports till 7 am on Tuesday.