Thursday, September 10, 2020

The Vaccine Race

There are currently nine coronavirus vaccine candidates in Phase 3 trials. 

One has suffered a setback when AstraZeneca "voluntarily paused" late-stage trials of the highly-anticipated Covid-19 vaccine they are developing with UK’s University of Oxford. It appears that one of the study volunteers developed an unexplained illness, the company said on Wednesday. 

The drug is in trials involving thousands of people in the United States, Brazil, South Africa and the UK, where the patient who fell ill is. 

Julie Fischer (right), an associate research professor in the Department of Microbiology and Immunology at the Center for Global Health Science and Security at Georgetown University, told Al Jazeera such a pause was "part of the process" of drug development and clinical trials. 

"For a pause, the event would need to be serious; something related to the heart, lungs, kidneys or other part of the body's health system that required medical attention and was sufficiently serious to merit a pause to this very important vaccine trial in order to make sure it is safe, and that the adverse effect is not due to the vaccine itself". 

Florian Krammer (left), professor of microbiology at the Icahn School of Medicine at Mount Sinai said the fact a patient had fallen ill underscored the need for extensive trials. 

"It shows you that the evaluation process works, and why we need Phase 3 trials", he wrote on Twitter. 

Clinical trial holds are not uncommon, but AstraZeneca's is the first phase-three Covid-19 vaccine trial known to have been put on hold. And it is unclear how long the suspension may last. 

Developers globally have yet to produce large-scale trial data showing actual infections in participants – but Russia approved a Covid-19 vaccine last month, prompting some Western experts to criticize a lack of testing. 

The head of China's Sinovac Biotech said most of their employees and their families have already taken an experimental vaccine developed by the Chinese firm under the country's emergency-use programme. 

It is interesting to point out that Dr. Stephen Hahn (right), the head of the Food and Drug Administration, the US regulator, had said last month that the normal approval process could be bypassed for a Covid-19 vaccine if officials were convinced the benefits outweighed the risks. 

Unsurprisingly, the comments prompted a call for caution from the World Health Organization. 

Separately, nine US and European vaccine developers promised on Tuesday to uphold scientific standards in the global race to contain the pandemic. The companies, including Pfizer, GlaxoSmithKline and AstraZeneca, in a joint statement made a "historic pledge... to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first Covid-19 vaccines". 

The unusual move to promise to play by well-established rules underlines the highly politicized debate over what action is needed to rein in the spread of the disease. 

In the US, Dr. Anthony Fauci (left), the Director of NIAID (National Institute of Allergy and Infectious Diseases) himself told The Washington Post's Bob Costa during a Post Live event on July 24 that a vaccine could be approved by or possibly before November 2020. 

As Health and Human Services Secretary Alex Azar (left) informed CNBC on July 22: "We are literally making the commercial scale vaccine now, as we're going through the clinical trials. We're doing that at-risk, using the full power of the US government and our financial resources to do that. No one's ever done this before". 

And in a radio interview on August 06 with Fox News correspondent Geraldo Rivera, President Donald Trump (right) too suggested that a vaccine for the coronavirus could be ready before Election Day. 

Trump also told an assembly of reporters that he was "optimistic" that a vaccine would be ready around November 03 and noted that while "It wouldn't hurt" his chances for re-election, he was doing it "to save a lot of lives".

The vaccine race is on.

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