It’s December 31, the end of the year, and India may be just a day away from approving a vaccine.
The Subject Matter Experts Committee (SEC) of the Central Medicines Standard Control Organization (CDSCO) on Wednesday reviewed data submitted by the Serum Institute of India and Bharat Biotech as requested at their last meeting. At that meeting, in response to the request for IBS emergency use authorization for Covishield (the name given by the company to the AstraZeneca / Oxford-developed vaccine that it is manufacturing here), the committee requested more data on safety and efficacy. The SEC also indicated that it would await approval of the AstraZeneca / Oxford vaccine by the UK’s drug regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA). The data was submitted last week, and on Wednesday morning, the MHRA approved the vaccine (phase 3 trials were conducted in the UK and Brazil; phase 3 trials in India are ongoing, and in progress). thinks some of the interim findings of that are: part of the data provided by the company).
Bharat Biotech is also believed to have presented some data, although it is unclear if this includes interim findings from its ongoing phase 3 trials.
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The SEC has said it will meet again on Friday. Covishield approval may come the same day.
This means that India could start vaccinating people from next week if everything else is in place.
A combination of circumstances and events has made it possible, but no one could have written it better: ending what could well be the worst year of this millennium with a cheap, locally made vaccine that is easy to transport and store is the best of all. possible outcomes. The new year will be more about vaccinations and vaccinations than anything else (even the new strain, which, as expected, has appeared in more places and people in India). As The Who sang, “Got a feeling ’21, it’s going to be a good year.”
The UK has said it will start vaccinating people with the AstraZeneca / Oxford vaccine on Monday. Phase 3 trials have shown that the vaccine is 62% effective when two full doses are administered. That compares unfavorably with the 95% efficacy shown by the Pfizer and Moderna vaccines, but over the weekend, the AstraZeneca CEO said. The Sunday Times that the company has submitted more data to the UK drug regulator showing that its effectiveness “after two doses is on par with all the others.” These data are yet to be published, but the 62% efficacy is not that bad; in fact, if AstraZeneca / Oxford had been the first to report the results of the phase 3 trials and published an efficacy number of 62%, the news would have been enthusiastically received.
Devastated by a new mutant strain of Sars-CoV-2 – the seven-day average of daily cases in the country is approaching 40,000; the December 29 count was around 53,000 – the UK has made the brave (and radical) decision to give a single shot of the two two-shot vaccines it has approved (Pfizer / BioNTech and AstraZeneca / Oxford) to as many people as possible. instead of stocking up for scheduled second takes. This could mean an increase in the time between the two injections up to 12 weeks, instead of the recommended four. The UK’s decision will affect the efficacy of vaccines for sure, only detailed studies will show to what extent, but the country’s hand may have been forced by the surge in cases that has already overwhelmed its healthcare system. India may be tempted to follow suit, but since the seven-day average of cases per day is at a minimum of six months, the country would do well to stick to its plan of giving 300 million people two injections of the vaccine in his country. top priority group (deadline to do so is June). Serum Institute expects to increase its capacity to 100 million doses per month in March and 300 million doses in July.
The challenges posed by the pandemic are not over, and 2021 will see more challenges related to what will be the world’s largest vaccination campaign, but a vaccine panel will be a welcome addition to HT’s Covid-19 database.
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