September 5, 2020 7:04:25 am
A booth displaying a coronavirus vaccine candidate from Sinovac Biotech Ltd is seen at the 2020 China International Trade in Services Fair (CIFTIS), following the COVID-19 outbreak, in Beijing, China on September 4, 2020. (Reuters photo: Tingshu Wang)
Coronavirus Vaccine Tracker (COVID-19): The race to produce a coronavirus vaccine has now turned into a race to produce it before the November 3 US presidential election. All the discussion about vaccines now centers on the question of whether a vaccine can be available, even theoretically, before then.
The events of the past few days suggest that, in America at least, that was the goal everyone was working towards. The Food and Drug Administration, the drug regulator, has said it was open to grant of emergency use authorization to a vaccine even before the completion of phase 3 trials, if initial results were promising. He said it was the responsibility of the vaccine developers to submit the emergency use authorization application and that if the FDA deemed the application “appropriate,” it could consider granting approval.
Thursday, Pfizer, one of the main contenders to produce the vaccine, said it hoped to obtain the effectiveness data phase 3 trials underway by the end of October, and if the results were satisfactory, it would move immediately to apply for FDA emergency use authorization.
In between, the Centers for Disease Control and Prevention told public health officials across the country to prepare for a targeted vaccination schedule “as early as late October or early November.”
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On Friday, Moncef Slaoui, senior adviser to the White House vaccine program, joined the discussion, saying it was “extremely unlikely,” though “not impossible,” that a vaccine will be available by the end of next month. He said the CDC directive for public health officials to be prepared was “the right thing to do,” because it would be “irresponsible” not to be prepared, if the vaccine were available next month.
But a vaccine before November 3 is largely a symbolic goal for the United States. It is not intended to be and cannot be available to large numbers of people. Only a few high-risk groups, such as the elderly with comorbid conditions or healthcare workers, would be selected for vaccination. And while some of the vaccine developers have already started manufacturing their doses, assuming everything will be fine and their candidates will eventually get regulatory approval, the volumes required for large-scale vaccination would not be possible by that deadline.
Add to that the growing skepticism among the American public about these accelerated vaccines. Successive surveys have revealed that a substantial proportion of the United States population was not very enthusiastic about taking a vaccine that had not followed standard procedures to ensure safety and efficacy. A new survey published in the USA Today on Friday he claimed that two-thirds of those polled were not in favor of getting an injection as soon as it was available, and at least 25 percent said they would never take it.
Read also | Reading the results of the Russian vaccine trial
And the race to be the first to produce a coronavirus vaccine is over. Chinese and Russian vaccines have already outperformed them all by a distant margin. At least three Chinese vaccines, in addition to the one developed by Russia’s Gamaleya Institute, have so far obtained regulatory approvals, although none of them have undergone phase 3 trials, a mandatory step under normal circumstances. These vaccines are now planning phase 3 trials, but simultaneously, they would also continue to be injected into the high-risk group.
The developers of the Russian vaccine have published the results of phase 1 and phase 2 trials, conducted in two Moscow hospitals, in The lancet magazine. The developers have claimed that their vaccine was not only safe, did not cause any adverse reactions in the 76 trial participants, but also elicited “strong” immune responses in the volunteers.
Search for the coronavirus vaccine: the story so far
- More than 175 vaccine candidates in preclinical or clinical trials
- 34 of them in clinical trials
- Eight in final stages, phase III human trials
- At least eight potential vaccines are under development in India. Two of them have entered phase II trials after completing phase I.
(As of Sept. 3; source: WHO Coronavirus Vaccine Overview Sept. 3, 2020)
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