Updated: August 31, 2020 10:00:05 am
US President Donald Trump gestures during a tour of a pharmaceutical manufacturing plant where components are being developed for a possible vaccine candidate for the coronavirus disease (COVID-19), in North Carolina (Reuters / Archive)
Coronavirus Vaccine Tracker (COVID-19): Raising the possibility of The United States receives a new coronavirus vaccine Earlier this year, the Food and Drug Administration, the country’s drug regulator, has said it may consider emergency clearance for a vaccine before the completion of phase 3 human trials.
In an interview with The Financial Times newspaper in London, FDA Commissioner Dr. Stephen Hahn said that vaccine developers had to apply for approval before phase 3 trials were finished. But in case any developer requested it, the FDA would consider it and not reject it for not having completed phase 3 trials, which is the last and most complete stage of testing a vaccine.
“We can find that appropriate (application). 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 political considerations. “This will be a science, medicine and data decision. This is not going to be a political decision, “he said.
Hahn also said that if the emergency use authorization is granted, it will most likely be approved for use only in particularly vulnerable groups and not all.
Hahn’s comments come at a time of intense political pressure from the Donald Trump administration to make a coronavirus vaccine available as soon as possible. Trump himself has repeatedly said that he believed the vaccine would be available in the US before the end of the year, most recently in the event to accept the Republican nomination to run for president again. He has even suggested that a vaccine could be ready before the US elections are held on November 3.
And last week, he directly attacked the FDA, saying the “deep state” Within the organization he was working to deliberately slow down the approval process for a vaccine in an effort to sabotage his bid for reelection.
Headquarters of the Food and Drug Administration in White Oak, Maryland. Photographer: Sarah Silbiger / Getty Images
At least one senior FDA official has gone public to say he would resign if you encountered any political pressure to prematurely approve a coronavirus vaccine. Speaking to the Reuters news agency last week, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said his resignation would mean something was wrong with the process.
“I couldn’t stand by and see something that was unsafe or ineffective happening. You have to decide where your red line is, and that’s my red line. I would feel obligated (to resign) because by doing so, I would signal to the American public that something is wrong, ”Marks said, as quoted.
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Most vaccine developers are working to a schedule of early next year to produce the coronavirus vaccine. But Russia and China they have already approved one vaccine each, without any of them having gone through phase 3 trials, which are planned to be done now. Both countries have come under heavy criticism for trying to cut corners in a rigorous process to produce a vaccine.
Third Chinese vaccine approved for emergency use
China is reported to have authorized the emergency use of a coronavirus vaccine being developed by Sinovac Biotech in 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 emerged 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 since July 22. Before that, a vaccine that CanSino Biologics was developing, in collaboration with the Academy of Military Medical Sciences, was approved for limited use in the last week of June. Of the 33 vaccines currently in clinical trials, eight are being developed by Chinese companies or institutions.
The governor of Brazil’s Sao Paulo state, Joao Doria, holds a box of China’s possible Sinovac coronavirus vaccine for trials in Sao Paulo, Brazil (Reuters / Archive)
Bangladeshi company to invest in Serum Institute and access coronavirus vaccines
Beximco Pharmaceuticals, part of one of Bangladesh’s largest industrial conglomerates, has reached an agreement with the Pune-based Serum Institute of India to access coronavirus vaccines in Bangladesh.
Serum, the world’s largest vaccine maker by volume, has agreements with at least two companies, whose vaccine candidates are among the top contenders to gain approval, 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 source the Serum Institute supplies. He said he would also invest in Serum, which would be considered an upfront payment for vaccines.
Bangladesh previously announced that it would conduct phase 3 trials of a vaccine being developed by China’s Sinovac Biotech.
SEARCH FOR THE CORONAVIRUS VACCINE: THE HISTORY UP TO NOW
- More than 175 vaccine candidates in preclinical or clinical trials
- 33 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.
(Source: WHO Coronavirus Vaccine Overview of August 28, 2020)
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