Coronavirus (COVID-19) Vaccine Tracker: Amidst concerns that normal regulatory processes were being by-passed to fast-track a coronavirus vaccine, nine major pharmaceutical companies promised to “adhere to high scientific and ethical standards” in development and manufacture of a coronavirus vaccine.
Among the nine companies are AstraZeneca, Moderna and Pfizer, whose coronavirus vaccine candidates are currently undergoing late-stage clinical trials. The other companies to sign on the joint statement are Novavax, Sanofi, GlaxoSmithKline, Johnson & Johnson, BioNTech, and Merck. Each of these companies is developing a coronavirus vaccine. BioNTech is collaborating with Pfizer on one vaccine.
The companies said they were pledging to “always make the safety and well-being of vaccinated individuals” their top priority, and that they will seek an approval for their vaccines only “after demonstrating safety and efficacy through a phase-3 clinical study”.
The statement comes at a time when the anxiety of the governments to be the first to make a coronavirus vaccine available to their publics has severely undermined the credibility of the scientific process being followed for the development of the vaccines, and created suspicion in the minds of people about their safety and effectiveness. Additionally, the coronavirus vaccine has also got caught in a political slugfest ahead of the November 3 Presidential election in the United States. President Donald Trump has said several times that it was possible that a coronavirus vaccine might become available before the election date.
Recent directives from the Food and Drug Administration, and the Centres for Disease Control and Prevention, in the United States also suggested that decks were being cleared for introduction of a vaccine into the market by November. A statement from Pfizer saying it expected effectiveness data from the ongoing phase-3 trials of its vaccine to become available by October also reinforced this impression.
The joint statement is therefore an attempt by the pharmaceutical companies to allay the fears of the public which is getting reflected in low enthusiasm for vaccines in several opinion polls conducted in the United States and Europe. The companies said they were committed to developing and testing potential vaccines “in accordance with high ethical standards and sound scientific principles”.
The companies have not ruled out seeking emergency use authorisations for their vaccines, but this too would happen only after the phase-3 trials. The US FDA has indicated that it was open to grant emergency use authorisations to suitable vaccine candidates even before phase-3 trials were completed if it was able to assess that the benefits outweighed the risks. Last week, Pfizer said it would seek emergency use authorisation immediately after preliminary effectiveness data from the ongoing phase-3 trials were available, which it expected to happen by October.
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Unlikely before November 3 election, says Anthony Fauci
Meanwhile, Anthony Fauci, an infectious disease expert and one of the most trusted voices in the United States on the coronavirus epidemic, has said a coronavirus vaccine was unlikely to be ready before the November 3 Presidential elections in the United States, as was being suggested.
Speaking at a health conference, Fauci said it was more likely that the vaccine would appear on the scene sometime before the end of the year.
Trump has repeatedly said that it was possible that a coronavirus vaccine would be in the market before the election date.
Till recently, Fauci had been maintaining that a vaccine would most likely be available only by early next year. But in the last few weeks, he had said that it was possible to expedite the development process further, and that he believed that end of this year was a realistic time frame for it to be ready.
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.
- The ones most talked about:
* AstraZeneca/Oxford University
* Johnson & Johnson
* Russian vaccine, developed by Gamaleya Insttiute in Moscow
(As on September 8; source: WHO Coronavirus vaccine landscape of September 3, 2020)