Pushback from leading developers, to pledge not to bring out their vaccines prematurely

Headlines


By: Explained Desk | Pune |

Updated: September 6, 2020 7:45:04 am


A visitor wearing a face mask takes a photo of a model of a coronavirus and boxes for COVID-19 vaccines at a display by Chinese pharmaceutical firm Sinopharm at the China International Fair for Trade in Services (CIFTIS) in Beijing (AP)

Coronavirus (COVID-19) Vaccine Tracker: While governments have been found more than willing to relax regulatory provisions to make a coronavirus vaccine available to their public at the earliest, a pushback now seems to be coming from the vaccine developers themselves.

According to a report in the Wall Street Journal, some of the top vaccine developers, including Pfizer, were planning to release a common statement, pledging not to seek regulatory approval for their products till their safety and effectiveness was firmly established. The report said the joint statement, planned to be released early next week, was still being prepared. Apart from Pfizer, US biotech company Moderna, and Johnson & Johnson, are also reported to be on board.

The companies were planning to promise to adhering to the highest scientific and ethical standards in developing and releasing their vaccines.

The move of the pharmaceutical companies comes at a time when the United States appears to be setting the stage for authorising emergency use of one of the vaccines in a few weeks time, possibly even before the November 3 Presidential elections. The Food and Drug Administration, the regulatory body in the United States, has publicly said that it was open to granting premature emergency use authorisation to a vaccine, if it was able to assess that the benefits of doing so outweighed the risks involved.

It said it would consider vaccine candidates for emergency approval even before their phase-3 trials were completed. Almost simultaneously, the Centres of Disease Control and Prevention (CDC) asked health authorities across the United States to be begin preparations for an early roll-out of the vaccine by November, or even earlier.

The rush to approve a vaccine in the United States seems to be being dictated by the November 3 election. President Donald Trump has repeatedly said that it was possible to make coronavirus vaccine available before that date, and has accused “deep state” with FDA of deliberately slowing down the approval process in order to sabotage his re-election chances.

📣 Express Explained is now on Telegram. Click here to join our channel (@ieexplained) and stay updated with the latest

Fresh controversy erupts at Moga CiVil hospital As of now, three leading vaccine candidates, those being developed by AstraZeneca and Oxford University, Moderna and Pfizer, are undergoing phase-3 trials. The Johnson & Johnson vaccine is in phase-2.

Incidentally, Pfizer, one of the companies planning to make the pledge against premature release of its vaccine, has also played a role in lending credence to the possibility of a vaccine being made available before November 3. Two days ago, the company said that, by the end of October, it was hoping to have enough data from the ongoing phase-3 trials to assess whether its vaccine was effective. It said if the data was satisfactory, it would immediately apply for seeking an emergency authorisation for its vaccine.

As of now, three leading vaccine candidates, those being developed by AstraZeneca and Oxford University, Moderna and Pfizer, are undergoing phase-3 trials. The Johnson & Johnson vaccine is in phase-2.

Pakistan among new countries where phase-3 trials of Chinese vaccine would be conducted

Out of the 34 vaccine candidates that are currently undergoing clinical trials, at least eight are being produced by Chinese companies. Three of these have already been approved for use, though none of them have completed phase-3 of clinical trials, a mandatory requirement for approval of vaccines under normal circumstances.

All the three candidates, being developed by state-owned Sinopharm, CanSino Biologics, and Sinovac Biotech, are now planning, or have started, phase-3 trials in multiple countries. On Saturday, Sinopharm and Sinovac Biotech said they had entered into agreements with new countries for the phase-3 trials of their vaccines.

Among the countries chosen for the trial of Sinopharm vaccine are Pakistan and Serbia, This vaccine is already being tested in UAE, Peru, Argentina, Morocco, Bahrain and Jordon, according to a Reuters report.

A box for a COVID-19 vaccine is displayed at an exhibit by Chinese pharmaceutical firm Sinopharm at the China International Fair for Trade in Services (CIFTIS) in Beijing (AP)

The Sinovac Biotech vaccine is currently undergoing phase-3 trials in Brazil and Indonesia. The company did not name the new locations for its trials.

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)

Also read | Reading Russian vaccine trial results

📣 The Indian Express is now on Telegram. Click here to join our channel (@indianexpress) and stay updated with the latest headlines

For all the latest Explained News, download Indian Express App.

© The Indian Express (P) Ltd



Source link