RDIF Rejects Unreliable Vaccine Technologies Due to Risks Exposed by AstraZeneca's Case

A syringe kept next to a small bottle labelled COVID19 vaccine for representational purposes

Shares of AstraZeneca AZN.L inched higher in early trade on Monday as the optimism spurred by the British drugmaker's resumption of clinical trials for its COVID-19 vaccine candidate outweighed official weekend moves to cut USA drug prices.

The alleged vaccine, dubbed Sputnik V, was developed by the Russian Healthcare Ministry's Gamaleya National Research Center for Epidemiology and Microbiology. On August 11, it became the world's first vaccine to get officially registered by a government. "It's a moment where countries don't want to hear this bad news, and I understand", Hans Kluge said, adding that we all have to "learn how to live with this pandemic".

"We are keen to explore if this may also be the case for SARS-CoV-2 and whether delivering COVID-19 vaccines to the respiratory tract is safe and produces an effective immune response", he said in a statement. More than 30 Europe-based experts signed an open letter this week publicly voicing their suspicion about the vaccine study, specifically noting "potential data inconsistencies".

He further stated: Issues such as vaccine safety, security, cost, cold chain requirements, equity, and production schedules, etc. have also been considered profoundly.

Still, the pause drew extraordinary attention because of the urgent need for progress on Covid-19 vaccines in the midst of the pandemic.

AstraZeneca claims that a "standard review process triggered a pause to vaccination to allow review of safety data" and had paused the programme as a participant had developed "unexplained illness".

According to instructions issued by DCGI following SII's response on September 10, the Pune firm will only be able to resume vaccination in the Indian trials of this vaccine candidate once it submits safety clearances from DSMB in India as well as the United Kingdom board that reviewed the global safety issue. He said: This must be done after the agreement, according to an official statement.

Serum Institute of India is the world's largest vaccine manufacturer by volume, producing 1.5 billion doses of vaccines annually for use in more than 170 countries to protect against many infectious diseases, such as polio, measles and influenza.

At the same time, the global coronavirus death toll has risen to 929,005, with more than 28 million infections on Monday. FDA Commissioner Stephen Hahn, insisting he wasn't being pressured by Trump to fast-track a vaccine, told The Financial Times last month the agency is prepared to bypass the full federal approval process in order to make a Covid-19 vaccine available as soon as possible.



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