The cases of the coronavirus disease (Covid-19) have mounted to over 35 million and 1,042,679 people have died across the globe even as the World Health Organization (WHO) said its “best estimates” indicate that 10% of people worldwide may have been infected by the coronavirus.
Dr Michael Ryan, WHO’s head of emergencies, said on Monday the figures vary from urban to rural and between different groups, but that ultimately it means “the vast majority of the world remains at risk.” He said the pandemic would continue to evolve, but that tools exist to suppress transmission and save lives. “Many deaths have been averted and many more lives can be protected,” Ryan said.
According to Ryan, southeast Asia faced a surge in cases, Europe and the eastern Mediterranean were seeing an increase in deaths, while the situations in Africa and the Western Pacific were “rather more positive.”
Researchers across the world are racing against time to develop a vaccine against the coronavirus disease as several of them have in advanced stages of the clinical trial.Vaccine development usually takes years, but scientists have been racing to shorten that time.
Here are the latest developments on Covid-19 vaccine:
1. Dr Reddy’s Lab asked to revise protocol for Russian Covid-19 vaccine trials
Dr Reddy’s Laboratories (DRL) has been directed by the expert panel of the Drugs Controller General of India (DCGI) to submit a revised protocol for performing phases 2 and 3 clinical trials of the Russian Covid-19 vaccine, Sputnik V, in India. Dr Reddy’s Lab had submitted an application to the top drug regulator seeking a nod to conduct clinical trials for the Russian Covid-19 vaccine in India.
“The Subject Expert Committee (SEC) had a thorough evaluation of the application submitted by Dr Reddy’s Lab. The SEC has sought revised protocol from Dr Reddy’s Lab along with more information and now Dr Reddy’s Lab has to furnish a fresh protocol to the DCGI,” a government official said, according to news agency ANI.
Dr Reddy’s Lab has joined hands with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of the Sputnik V vaccine as well as its distribution. RDIF has said it will supply 100 million doses of its potential Covid-19 vaccine to Dr Reddy’s Lab.
2. Regeneron antibody cocktail used by Trump faces patent suit
According to a lawsuit by a California company that patented the technology, the Regeneron Pharmaceuticals Inc “antibody cocktail” given to US resident Donald Trump to treat his Covid-19 symptoms was developed with the unauthorised use of a fluorescent protein.
Allele Biotechnology and Pharmaceuticals Inc sued Regeneron on Monday in White Plains, New York, seeking royalties for the use of its mNeonGreen protein in developing the experimental treatment. A separate federal lawsuit was filed in California against Pfizer Inc and BioNTech SE, partners in the race to develop a Covid-19 vaccine.
A fluorescent protein is injected into cells so researchers can watch what’s happening — to determine, for example, how a virus reacts to an antibody. The patent for mNeonGreen, issued in March 2019, covers the use of the protein, which Allele said scientific journals have dubbed the “gold standard” for testing the efficacy of antibody and vaccine candidates.
3. White House blocked tougher FDA guidelines on vaccine approval
The New York Times reported on Monday that White House officials are blocking new federal guidelines for the emergency release of a coronavirus vaccine, including one that would likely ensure that no vaccine could be authorised before the presidential election on November 3.
The US Food and Drug Administration submitted the guidelines to the Office of Management and Budget more than two weeks ago, but they stalled with White House Chief of Staff Mark Meadows, the Times reported, citing people familiar with the approval process.
According to Reuters, an administration official that the approval process was still pending and denied any Election Day connection. The FDA is seeking other avenues to ensure that vaccines meet the guidelines, the Times reported.
FDA Commissioner Stephen Hahn has pledged that career scientists, not politicians, will decide whether any coronavirus vaccine meets clearly stated standards that it works and is safe.