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Coronavirus vaccine update: SII to change trial protocol; Russian candidate may be approved by Aug 12

Coronavirus vaccine news update: Serum Institute of India has been asked by Drug Controller General of India (DCGI) to change its protocol for Phase 2 and 3 trials of Oxford University-AstraZeneca COVID-19 vaccine

twitter-logoBusinessToday.In | July 30, 2020 | Updated 15:18 IST
Coronavirus vaccine update: SII to change trial protocol; Russian candidate may be approved by Aug 12
Coronavirus vaccine news: FDA may issue emergency use authorisation

In the run up to a coronavirus vaccine, new alliances are being formed and regulatory processes sped up. As leading contenders aim to get clearances by 2020-end to launch their COVID-19 vaccine candidate, the light at the end of the tunnel does not seem far. Nevertheless, some experts believe that it would still take as long as mid-2021 for a coronavirus vaccine to be widely available in the market. Research Minister Anja Karliczek said any vaccine is unlikely to be widely available before the middle of next year. "We should not expect a miracle. We must continue to assume that vaccines for the broader population will only be available from the middle of next year at the earliest," said Karliczek. She also urged people to maintain social distancing and mask-wearing to avoid jeopardising what has been achieved so far in the battle against COVID-19.

Even with the availability of a COVID vaccine, experts believe that there would be long-term demand for a vaccine. Makers of one of the leading contenders, Pfizer, believes that the coronavirus vaccine could be more or less like an inoculation that would require upkeep to be effective. "There is a likely scenario that either the vaccine's immunity will not be lasting forever, or that the virus will mutate, or that the virus will find ways to come back again and again," said Chief Executive Officer Albert Bourla.

Also read: Coronavirus vaccine news update: India readies 5 sites for trials; Oxford, Pfizer advance to late-stage

Meanwhile, the US Food and Drug Administration (FDA) is likely to issue emergency use authorisation of a COVID-19 vaccine within weeks after it meets all safety and efficacy requirements. "We stand ready for using emergency use authorisation (EUA) in an appropriate setting," said Dr Peter Marks, director of the FDA Center for Biologics Evaluation and Research. EUA would approve the coronavirus vaccine on an expedited basis.

Here are the latest developments on COVID-19 vaccine from India and the world:

Oxford-AstraZeneca vaccine: Serum Institute of India has been asked by Drug Controller General of India (DCGI) to change its protocol for Phase 2 and 3 trials. A Central Drugs Standard Control Organisation (CDSCO) panel has sought clarification from the manufacturer. "The company on Tuesday was asked to clearly define phase 2 and phase 3 part of the protocol and resubmit their application for evaluation by the SEC," an official said. The panel has also asked the manufacturer to distribute the sites of tests across the country. SII has also been asked to justify the proposed enrolment of 1,600 volunteers for the trials. SII that is manufacturing Oxford University-AstraZeneca's COVID-19 vaccine candidate had submitted its application to DCGI seeking permission for Phase 2 and 3 trials of Covishield.

Also read: Russia likely to approve world's first coronavirus vaccine by August 10

Meanwhile, health workers in Brazil are volunteering for trials. Researchers would run a controlled experiment to test the efficacy of the coronavirus vaccine. As many as 5,000 volunteers would help test the Oxford University-AstraZeneca vaccine. Half of the volunteers would receive the vaccine while the other half would be administered the placebo.

Russia's Gamaleya vaccine: Russia has said that the vaccine developed by Moscow's Gamaleya Research Institute of Epidemiology and Microbiology is likely to be approved for public use by August 10-12. Russia had said earlier that this vaccine was successfully completed human trials. The vaccine has not yet completed its three rounds of trials. However, Bloomberg stated that the Gamaleya vaccine was likely to get "conditional registration" in August, which means that it would be approved for use even as Phase 3 trials are carried out. Production is expected to begin in September.

Sinopharm: Chinese company Sinopharm and Parana have said that it will launch the fourth major COVID-19 vaccine trial in Brazil. Jorge Callado, head of the Parana Technology Institute (Tecpar), said they would soon finalise their proposal and submit it for approval with federal health regulator Anvisa. Sinopharm's candidate vaccine is already being tested in the United Arab Emirates with 15,000 volunteers.

Also read: Serum Institute's proposal for Oxford COVID-19 vaccine trial deferred

Also read: Coronavirus vaccine: Why Americans will pay lot more than Indians for COVID-19 vaccine

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