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Coronavirus vaccine update: Search on for single-dose vaccine; Serum Institute gets approval for Phase 2, 3 trials

BusinessToday.In     August 3, 2020

Coronavirus vaccine makers are now faced with a new hurdle -- single dose vaccines. As pharmaceutical companies make headway, the focus is now to formulate single dose vaccines. One-dose vaccines are not only convenient, it also would be cheaper for the patients. Not to mention, single-shot COVID-19 vaccines would have better global deployment. However, most of the frontrunners in the COVID vaccine race are double-shot vaccines, including Moderna and Pfizer-BioNTech's candidates. Meanwhile, Oxford-AstraZeneca are testing single-shot vaccines. Johnson and Johnson is testing both.

Immunogenicity or the amount of immune response generated by a vaccine is at the crux of this research. Too little immunogenicity means that the vaccine is ineffective and too much means the vaccine could produce side effects.

However, two-shot vaccines are not all that bad. Sometimes, it also means that it could have a longer, sustained immune response. Dr. Dan Barouch, professor of medicine at Harvard Medical School told ABC News, "We know that a second shot will likely increase the immune responses. We do think a two-shot vaccine would raise more robust response." But once the first shot is administered, people might get complacent and not seek a second shot. That would mean the course is incomplete and would only provide minimal protection.

Also read: Coronavirus vaccine update: Eyes on India as candidates race towards finish line

Pharmaceutical giant AstraZeneca has also said that coronavirus might require annual vaccination. "But the truth is that we don't know, this virus is very unpredictable," said CEO Pascal Soriot.

"What we know is that most companies are targeting two injections for the initial vaccination and then our own assumption based on what we know from the technology we use with SARS 1 is that the immunity could last 12 months maybe 18 months," said Soriot.

Here are the updates from India and across the world:

Oxford University-AstraZeneca: Pune-based Serum Institute of India has received the approval of Drugs Controller General of India (DCGI) to conduct Phase 2 and 3 human trials in India. The approval was granted late Sunday night after a thorough evaluation based on the recommendations  of Subject Expert Committee (SEC). "The firm has to submit safety data, evaluated by the Data Safety Monitoring Board (DSMB), to the CDSCO before proceeding to Phase 3 clinical trials," a senior official said. Each subject will be administered two doses in a gap of four weeks (first dose on day one and second dose on day 29) following which the safety and efficacy will be assessed. Phase 2 and 3 clinical trials of the Oxford vaccine is already underway in the UK, Brazil and South Africa. Around 1,600 people above 18 years of age will participate in the trials across 17 selected sites.

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

Russian vaccines: Russia is planning to launch a nationwide vaccination campaign in October. The candidate, is however, yet to complete its trials. Health Minister Mikhail Murashko said that they would start vaccinating health workers and teachers first. The COVID-19 vaccine candidate has been developed by Gamaleya Institute in Moscow.

Not only that, the country is gearing up for the mass production of another vaccine by November. Vector State Research Center of Virology and Biotechnology plans to start production of its coronavirus vaccine in November. "We expect to start production already in November this year. So, closer to the end of the year and the start of the next year we can talk about switching to vaccination at least for [people] from risk groups with a further switch to massive vaccination," Director-General Rinat Maksyutov said.

Sanofi-GlaxoSmithKline: Sanofi and GlaxoSmithKline have said that they are in advanced discussions to supply up to 300 million doses of an experimental COVID-19 vaccine for the 27-country European Union. The EU wants to ink deals with six drugmakers for their coronavirus vaccine for 450 million citizens. "It is envisaged that, once a vaccine has proven to be safe and effective against COVID-19, the Commission would have a contractual framework in place for the purchase of 300 million doses, on behalf of all EU member states," it said in a statement.

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


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