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Coronavirus vaccine tracker, Aug 31: FDA could approve shots before phase-3 trials are completed

Coronavirus (COVID-19) vaccine tracker August 31 Update: Commissioner Dr Stephen Hahn said the FDA could consider approving vaccines before phase-3 trials were over.

By: Explained Desk | Pune |
August 31, 2020 8:19:43 am
US President Donald Trump gestures during a tour a pharmaceutical manufacturing plant where components for a potential coronavirus disease (COVID-19) vaccine candidate are being developed, in North Carolina (Reuters/File)

Coronavirus (COVID-19) Vaccine Tracker: Raising the possibility of the United States getting a novel coronavirus vaccine this year itself, the Food and Drug Administration, the country’s drug regulator, has said it could consider emergency authorisation to a vaccine before the completion of phase-3 human trials.

In an interview to The Financial Times newspaper in London, FDA commissioner Dr Stephen Hahn said it was up to the vaccine developers to apply for approval before phase-3 trials were over. But in case, some developer did apply, FDA would consider it, and not reject it for not having completed phase-3 trials, which is the last and most comprehensive stage of testing of a vaccine.

“We may find that (application) appropriate. We may find that inappropriate. We will make a determination,” Hahn said.

But he said the decision would be based on science and data and not on political considerations. “This is going to be a science, medicine, data decision. This is not going to be a political decision,” he said.

Hahn also said that if the emergency use authorisation was indeed given, it would most likely be approved for use only in particularly vulnerable groups and not on everyone.

Hahn’s comments come at a time of intense political pressure from the Donald Trump administration to make a coronavirus vaccine available as early as possible. Trump himself has repeatedly said he believed a vaccine would be available in the US before the end of the year, most recently at the event to accept the Republican nomination for running for Presidency again. He has even suggested that a vaccine could be ready before the US elections are held on November 3.

And last week, he made a direct attack on the FDA, saying the “deep state” within the organisation was working to deliberately slow down the process of approving a vaccine, in an effort to sabotage his re-election bid.

Food And Drug Administration headquarters in White Oak, Maryland. Photographer: Sarah Silbiger/Getty Images

At least one top official of the FDA has gone public to say he would resign if he came across any political pressure to prematurely approve a coronavirus vaccine. In remarks to Reuters news agency last week, Peter Marks, director of FDA’s Centre for Biologics Evaluation and Research, said his resignation would mean something was wrong with the process.

“I could not stand by and see something that was unsafe or ineffective that was being put through. You have to decide where your red line is, and that’s my red line. I would feel obligated (to resign) because in doing so, I would indicate to the American public that there is something wrong,” Marks was quoted as saying.

Most vaccine developers are working with a timeline of early next year to produce the coronavirus vaccine. But Russia and China have already approved one vaccine each, without either of them going through phase-3 trials, which are being planned to be done now. Both the countries have come under heavy criticism for trying to take shortcuts in an otherwise rigorous process to produce a vaccine.

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Third Chinese vaccine approved for emergency use

China is reported to have authorised the emergency use of a coronavirus vaccine being developed by Sinovac Biotech on high-risk groups, according to a report by Reuters news agency. This is the third coronavirus vaccine that has been approved for limited use in China. None of them have completed clinical trials.

Last week, it had become known that a vaccine being developed by state-owned Sinopharm, which is currently undergoing phase-3 trials in the United Arab Emirates, was being administered to some people from July 22. Before that, a vaccine being developed by CanSino Biologics, in collaboration with Academy of Military Medical Sciences, was approved for limited use in the last week of June. Of the 33 vaccines currently undergoing clinical trials, eight are being developed by Chinese companies or institutions.

Brazil’s Sao Paulo state governor, Joao Doria holds a box of the China’s Sinovac coronavirus potential vaccine for trials in Sao Paulo, Brazil (Reuters/File)

Bangladesh firm to invest in Serum Institute, access Covid-19 vaccines

Beximco Pharmaceuticals, part of one of the biggest industrial conglomerates in Bangladesh, has entered into a deal with Pune-based Serum Institute of India to access coronavirus vaccines for Bangladesh.

Serum, the world’s largest manufacturer of vaccines by volume, has agreements with at least two companies, whose candidate vaccines are among the leading contenders to get approval, to produce their vaccines in India, and market them in other low and middle income countries.

Beximco has said it would be among the first countries to get the supplies from Serum Institute. It said it would also invest in Serum, which would be considered advance payment for the vaccines.

Bangladesh has earlier announced that it would conduct phase-3 trials of a vaccine being developed by China’s Sinovac Biotech.

HUNT FOR CORONAVIRUS VACCINE: THE STORY SO FAR

  • More than 175 vaccine candidates in pre-clinical or clinical trials
  • 33 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.

(Source: WHO Coronavirus vaccine landscape of August 28, 2020)

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