India set to become next big hub for COVID-19 vaccine production; UK begins review for AstraZeneca’s candidate

AstraZeneca says UK’s health regulator has started an accelerated review of its experimental coronavirus vaccine jointly developed with the University of Oxford.

KEY HIGHLIGHTS

  • The novel coronavirus has caused a global pandemic of historic proportions in the 10 months since cases were first reported in Wuhan, China
  • A safe and effective vaccine is essential combat the pandemic and allow resumption of the many activities of normal life
  • The first phase 3 efficacy data from the leading vaccine candidates are due by the end of 2020

New Delhi: Scientists and drugmakers all over the world are racing against time to develop a safe, effective vaccine against COVID-19, the disease caused by the SARS-CoV-2 virus. However, experts have raised concerns about making enough doses for everyone if and when a vaccine arrives. A new global study suggested that India has an edge in the global vaccine race. The country currently has three COVID-19 vaccines, including two indigenous candidates, that are in different phases of clinical evaluation.

Recently, the  Drug Controller General of India (DCGI) allowed Dr Reddy’s Laboratories and RDIF to conduct an adaptive phase 2 and 3 human clinical trials for Sputnik V COVID-19 vaccine in the country. Meanwhile, British-Swedish multinational pharmaceutical and biopharmaceutical company AstraZeneca has said that UK’s health regulator has started an accelerated review of its experimental coronavirus vaccine jointly developed with the University of Oxford even as Britain is gearing up to approve the first successful shot at the earliest possible.

All eyes set on India to become the next big hub for vaccine production

A new global analysis of advance market commitments (AMCs) for experimental vaccines against COVID-19 has shown that India is looking to secure 600 million doses of vaccine and negotiate for another billion doses by leveraging its manufacturing capacity. The total number of these vaccine doses, if they are approved for use in the course of time, should be enough to vaccinate half of the country’s population, reported IANS. Experts have said that the global manufacturing capacity for vaccines is vastly inadequate for the billions of doses that are needed, which is a major challenge.

At least three vaccines are being tested in India. These include Bharat Biotech and ICMR’s Covaxin, Zydus Cadila’s ZyCoV-D, and the Oxford-AstraZeneca’s candidate, dubbed Covishield in India, being handled by the Serum Institute of India (SII). Hyderabad-based Bharat Biotech said it is planning to launch COVAXIN in the second quarter next year if it gets the requisite approvals from the regulatory authorities.

Last week, drug major Dr Reddy’s Laboratories announced its partnership with the Biotechnology Industry Research Assistance Council (BIRAC) for advisory support on clinical trials of the Sputnik V vaccine in the country.

On September 4, a research paper on the results of phase 1 and 2 clinical trials of the Sputnik V vaccine was published in The Lancet, one of the leading international medical journals, demonstrating no serious adverse effects and a stable immune response in 100 per cent of participants.

Russian President Vladimir Putin, speaking at an investment forum, expressed hope to start the mass production of COVID-19 vaccines sooner that late by willing to collaborate with nations worldwide.

“We are ready to agree to produce this vaccine or these vaccines at the production sites of our foreign partners. They have this equipment, and I want to emphasise this, not to the detriment, vaccination in Russia itself, since we still have to purchase or develop this equipment, we are ready to work with our foreign partners,” said Putin on Thursday.

Some experts in India have lauded Putin’s comments and find it very encouraging, while also adding that the time is ripe for India to leapfrog and become the next big hub for vaccine production.

“With Russia’s willingness to collaborate with other nations worldwide, India has the potential to become the next big hub for vaccine production. COVID-19 that has had a huge impact on human lives and overall economic growth of the country, needs our immediate attention. Many countries are working tirelessly to develop a vaccine for treating the dreadful virus,” said Dr Dhirendra Kumar, Assistant Director at National Center For Disease Control.

“Russia has recently expressed the willingness to produce vaccines at foreign sites. It is very encouraging and a huge opportunity for India which is among the largest manufacturer of generic drugs and vaccines in the world. It is home to half a dozen major vaccine makers which are developing vaccines against the virus that causes Covid-19. With India’s increasing experience in manufacturing vaccines and a crucial role in product innovation that is affordable, the country is foreseen as a growing vaccine hub. About 60% of all vaccines worldwide are manufactured in India and it can be the world’s door to vaccine,” Dr Gajendra Singh, a public health expert, added.

According to Dr Dhirendra Kumar, the Russian vaccine that is developed by the Gamaleya institute is based on a proven technological platform using human adenovirus.

UK begins accelerated review for Oxford’s AstraZeneca’s Covid-19 vaccine

On Sunday, AstraZeneca confirmed that Britain’s health regulator has begun an accelerated review of its COVID-19 vaccine candidate.

“We confirm the MHRA’s (Medicines and Healthcare Products Regulatory Agency) rolling review of our potential Covid-19 vaccine,” an AstraZeneca spokesman was quoted as saying.

Recently, the company announced that the AZD1222 covid-19 vaccine, based on a chimpanzee adenovirus called ChAdOx1, has shown strong immune responses among the elderly as well as younger participants. Last Friday, Bloomberg reported that the MHRA had also initiated an accelerated review for Pfizer Inc’s Covid-19 vaccine candidate.