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Coronavirus Briefing Newsletter – Times of India

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Box
THE COUNT
  • India’s health ministry Sunday confirmed 30,948 new cases and 403 fatalities, raising the total to 32,424,234 cases (353,398 active cases) and 434,367 fatalities.
  • Worldwide: Over 211.4 million cases and 4.42 million fatalities.
  • Vaccination in India: 580,602,518 doses. Worldwide: Over 4.9 billion doses.
TODAYS’ TAKE
Why it’s time to compare vaccines with vaccines
Why it’s time to compare vaccines with vaccines
  • The government plans to disallow the use of placebo in clinical trials of upcoming Covid-19 vaccines and, instead, allow companies to use an existing vaccine (such as Covishield or Covaxin) to assess the immunogenicity and efficacy of the new vaccine, reports The Economic Times. Placebo is an inactive drug or treatment used in clinical trials.
  • One of the reasons officials cited for the proposed change is that participants placed in the placebo arm in such trials will lose out on vaccines. Some experts had called for such a change in trials.
  • “A placebo arm was justified when there was no vaccine available, but depriving a person of the currently available standard of care is unethical,” Amar Jesani, editor of Indian Journal of Medical Ethics says. “In a trial, 50% of the participants get vaccines while the rest who are in a placebo arm do not get any. Why should one join a trial when a vaccine is easily available?” he says.
  • In phase 3 trials of Covovax — Serum Institute of India’s version of Novavax’s Covid-19 vaccine — the Drugs Controller General of India (DCGI) has already approved conducting the clinical trials by doing away with placebo.
  • Some experts said making a comparison of various Covid-19 vaccines is difficult because they are developed on different technology platforms.
  • Ideally, vaccines from the same platform should be used as a comparator, they said, adding that the unavailability of mRNA vaccines like Pfizer and Moderna vaccines in India poses a challenge for Gennova’s vaccine candidate.
  • According to a recent article in New England Journal of Medicine (NEJM), a long-standing practice in research has called for either stopping the ongoing trials when a successful product is available outside such trials or at least informing trial participants so that they may leave the study in order to access the newly available product.
TELL ME ONE THING
Vaccine approvals are speeding up, but vaccinations aren’t
Vaccine approvals are speeding up, but vaccinations aren’t
  • With Zydus Cadila’s ZyCoV-D expected to roll out from mid-September, India will have six Covid-19 vaccines that have been approved by the authorities. And yet, daily vaccination numbers seem to be stuck at little over 50 lakh doses.
  • Already, India has revised its requirement of the vaccine doses for this year downwards by 37.5% — from 2.16 billion the Centre said it will need in order to inoculate all adults by December 31, to 1.35 billion as an affidavit it filed in the Supreme Court in June.
  • A major problem is the time being taken to ramp up production capacity — while Zydus Cadila will be able to manufacture 1 crore doses a month from October after its new plant is operational, Serum Institute’s Covishield’s production capacity, currently at 11 crore doses a month, will go up to 12 crore from September while Bharat Biotech’s Covaxin’s monthly production numbers are expected to increase from 2.5 crore doses to 5.8 crore doses from September.
  • Of the other approved vaccines — Sputnik, Moderna’s and Johnson & Johnson’s (J&J) — there’s only limited availability of the Russian-made Sputnik, which is currently being imported and till July, just 3.3 million doses had been delivered. Of the other two, while Cipla has been given the nod to import Moderna’s vaccine, it’s unlikely to be available before next year, while the emergency use authorisation (EUA) for J&J’s single dose vaccine came only earlier this month — suggesting that its availability may also happen only in the distant future.
  • India’s desired target of administering 1 crore doses a day, in order to fully vaccinate its adult population by December 31 this year, is only likely if vaccine production capacity is between 25-30 crore doses a month. Current production capacity however, is barely at 50% of that level.
  • The slow take off of vaccine production numbers is likely to impact not just the vaccination target for the first dose but also the availability of vaccines for the second dose. Of the little over 58 crore who have been vaccinated, just about 13 crore people have received both their doses. The number of people due for their second dose are expected to rise now as those who received their first dose in May — when the increased dosage interval of 12-16 weeks came into effect — will be queuing up for their second shot in the coming days.
  • Lack of vaccine availability will also put a pressure on the government to reduce the dosage interval even as the National Technical Advisory Group on Immunisation in India (NTAGI), which is expected to take a decision in this regard in the coming days, said to be in favour of reducing the gap for all adults aged 45 and above.
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Written by: Rakesh Rai, Judhajit Basu, Sumil Sudhakaran, Tejeesh N.S. Behl
Research: Rajesh Sharma


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August 22, 2021, 9:44 am





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