The United States drug regulator, Food and Drug Administration (FDA), has asked developers of coronavirus vaccine to monitor the health of trial participants for at least two months before applying for an approval.
The new stricter guidelines issued by the FDA on Tuesday almost rules out all chances of a vaccine becoming available, or getting approved, before the US Presidential elections on November 3, something that President Donald Trump has repeatedly said was possible.
The guidelines were finalised and sent for President’s approval about two weeks ago, but the White House had been sitting over it all this while, according to a report in The New York Times. The approval finally came on Tuesday.
Four leading candidates for coronavirus vaccine are currently undergoing phase-3 clinical trials, the last stage of testing, in the United States. Pfizer has said that it hoped to get reliable data on the effectiveness of its vaccine in the month of October itself. It has said if the effectiveness data was satisfactory, it would immediately apply for emergency use approval for its vaccine. Pfizer’s timeline had triggered speculation that a vaccine might indeed get approved before the November 3 date.
However, FDA’s new guideline could delay such ambitious timelines. The new guidelines also ask the developers to submit additional data on their trial participants, including on those who have been administered a dummy instead of the actual vaccine.
The trials of AstraZeneca vaccine, stopped a month ago after one of the trial participants in the UK had developed a serious ailment, are yet to resume in the United States. The US authorities have ordered an investigation into the entire episode, even though trials in other countries, UK, Brazil, South Africa and India, have re-started.
The two other companies, whose vaccines are in phase-3 trials, Moderna and Johnson & Johnson, have said they hoped that their vaccine would be ready early next year.
Russia has been developing another coronavirus vaccine, its second, and is speeding up its development to ensure an approval by the middle of this month, a report in The Wall Street Journal said.
Russia’s first vaccine, approved by the country’s regulator on August 12, had been widely criticised because it had not undergone phase-3 clinical trials, something that is being initiated only now. It was later clarified that the approval was only conditional, and for emergency use, and that it was contingent on phase-3 trials being conducted later.
That vaccine is already being administered in Russia, and is planned to be used by other countries as well, including India. Hyderabad-based Dr Reddy’s Laboratories has entered into an agreement to distribute the vaccine in India. But before it can be used on Indian population, the Russian vaccine, as is the case with any vaccine developed outside the country, would have to undergo late stage clinical trials in India. Those trials are expected to begin next month.
The Wall Street Journal said the second vaccine was being developed by a former Soviet bioweapons research laboratory called Vector State Virology and Biotechnology Centre. It quoted the Russian Health Minister as saying that he expected the vaccine to get the approval as early as mid-October.