AstraZeneca's India partner Serum Institute of India (SII) may have to conduct additional tests for a half-dose approval. The report comes after the British-Swedish drugmaker and the University of Oxford said on November 23 that their coronavirus vaccine was 70.4 percent effective, on an average, in preventing COVID-19
According to a report by The Indian Express, in order to get approvals to market a version of 'Covishield' that is more effective in preventing symptomatic COVID-19 cases, SII might have to conduct some additional tests.
Preliminary results on the AstraZeneca vaccine were based on a total of 131 COVID-19 cases in a study involving 11,636 participants.
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In Brazil, two full doses of the vaccine were given one month apart, involving 8,895 participants and appeared to be 62 percent effective, while half dose, followed by a full dose, was given in the UK, involving a much smaller subset of 2,741 participants. Here the vaccine demonstrated 90 percent effectiveness. The average efficacy of both the dosing regimens put together was 70.4 percent.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
According to the report, in India, Covishield is being administered as two full doses 28 days apart to over 1,600 participants. An official told the newspaper that SII, since it had sought permission to test the full dose regimen, can only seek permission to administer the vaccine in a full dose regimen.
"... They (SII) have to ask for (emergency use authorisation) for full dose regimen only," an official told the newspaper, adding that if they ask marketing permission for half-dose, trials for that will have to be conducted.
According to an official, the testing for this additional regimen may not be as drawn out, though, since SII could apply to the Central Drugs Standard Control Organisation (CDSCO) to include the testing as a "separate arm" in the ongoing vaccine trials in India."If they are using only the full-dose regimen, it is likely that Covishield may come out with a similar efficacy readout of around 60 percent. This would be still enough for them to apply for approvals from Indian drug regulator, because its guidelines suggest that a vaccine has to meet efficacy of around 30 to 50 percent for a COVID-19 vaccine to receive approval," vaccine expert Dr Davinder Gill told the newspaper, adding that while a lower efficacy might not be an issue at this point, it might make a difference a year from now.