September 5, 2020 7:04:25 am
Coronavirus (COVID-19) Vaccine Tracker: The race for producing a coronavirus vaccine has now got converted into a race to produce it before the November 3 US Presidential elections. The entire discussion on vaccines is now centred around the question whether a vaccine can be made available, even notionally, before that date.
Developments of the last few days suggest that, at least in the United States, that was the goal everyone was working to achieve. The Food and Drug Administration, the drug regulator, has said it was open to granting emergency use authorisation to a vaccine even before the completion of the phase-3 trials, if the initial results were promising. It said it was up to the vaccine developers to make the application for emergency use authorisation, and if the FDA found the application “appropriate”, it may consider granting approval.
On Thursday, Pfizer, one of the leading contenders to produce the vaccine, said it was hoping to get the effectiveness data from the ongoing phase-3 trials by the end of October, and if the results were satisfactory, it would move immediately to seek emergency use authorisation from the FDA.
In between, the Centres for Disease Control and Prevention told public health officials all over the country to be prepared for a vaccination programme for targeted groups “as soon as late October or early November”.
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On Friday, Moncef Slaoui, chief advisor for White House’s vaccine programme, joined the discussion, saying it was “extremely unlikely” though “not impossible” for a vaccine to be made available by the end of next month. He said the CDC directive to public health officials to be ready was the “right thing to do”, because it would be “irresponsible” not to be ready, if the vaccine indeed was available by next month.
But a vaccine before November 3 is largely a symbolic goal for the United States. It is not meant to be, and cannot be, made available to a large number of people. Only a few high-risk groups, like elderly with co-morbid conditions or healthcare workers, would be selected for vaccination. And though some of the vaccine developers have already started manufacturing their doses, assuming that everything will go well, and their candidates would ultimately get the regulatory approval, the volumes required for largescale vaccination would not be possible by that deadline.
Add to that the increasing scepticism amongst the US public to these fast-tracked vaccines. Successive polls have revealed that a substantial proportion of the population in the United States was less than enthusiastic about taking a vaccine that had not followed the usual procedures for ensuring safety and effectiveness. A new poll published in the USA Today on Friday claimed that two-thirds of the respondents were not in favour of getting a shot as soon as it was available, and at least 25 per cent said they would not take it ever.
Also read | Reading Russian vaccine trial results
And, the race to be the first one to produce a coronavirus vaccine is already over. The Chinese and the Russian vaccines have already beaten everyone by a distant margin. At least three Chinese vaccines, apart from the one developed by Russia’s Gamaleya Institute, have so far won regulatory approvals, though none of them has undergone phase-3 trials, a mandatory step in normal circumstances. These vaccines are now planning phase-3 trials, but simultaneously, they would also continue to be injected on high-risk group.
The developers of the Russian vaccine have published results of phase-1 and phase-2 trials, conducted in two hospitals in Moscow, in The Lancet magazine. The developers have claimed that their vaccine was not just safe — it did not elicit any adverse reaction on the 76 participants in the trials — it also triggered “strong” immune responses in the volunteers.
Hunt for coronavirus vaccine: The story so far
- More than 175 vaccine candidates in pre-clinical or clinical trials
- 34 of them in clinical trials
- Eight in final stages, phase-III of human trials
- At least eight candidate vaccines being developed in India. Two of these have entered phase -II trials after completing phase-I.
(As on September 3; source: WHO Coronavirus vaccine landscape of September 3, 2020)
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