The August 15 deadline for Bharat Biotech’s vaccine may reflect this political pressure
India has set an ambitious schedule for its first potential coronavirus vaccine – from human trials to general use in six weeks.
Bharat Biotech International Ltd., an unlisted vaccine manufacturer, received regulatory approval to begin human clinical trials for its experimental vaccine earlier this week and it already has the best medical research organization in India to accelerate the process.
The vaccine under development is “scheduled” to be deployed “for public health purposes by August 15 after the completion of all clinical trials,” said the Indian Council for Medical Research, or ICMR, in a letter dated July 2 to clinical trial sites, which was seen by Bloomberg News. It is “one of the priority projects which is the subject of monitoring at the highest level of the government”.
There is no evidence yet that the Bharat Biotech vaccine is safe for use in humans, let alone its effectiveness. The planned timeline is significantly shorter than other leading immunization efforts by American and Chinese drug manufacturers, most of which started human clinical trials months ago and are now entering the last of three stages of testing.
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The nomination underscores India’s urgent need to end the coronavirus, which has sickened more than 6.97,000 people and killed more than 19,600 in the Asian nation – the third largest epidemic in the world. In its letter, the ICMR urged test sites to register volunteers before July 7.
The speed alarmed some in the medical fraternity. “Such a path of accelerated development has never been done for any type of vaccine, even those tested in other countries,” said Anant Bhan, medical researcher at Manipal University in India, in a message on Twitter. “Even with accelerated deadlines, it seems rushed and therefore, with potential risks.”
After abandoning an expensive foreclosure that has caused enormous economic suffering without slowing the spread of the virus, Prime Minister Narendra Modi’s government is impatient to plan to control the epidemic.
Political pressure
The August 15 deadline for Bharat Biotech’s vaccine may reflect this political pressure: it is the day when India celebrates the independence of the British, marked by a national speech by Prime Minister Modi.
The letter to investigators from clinical trial sites aimed to cut unnecessary red tape, without bypassing any necessary process, and to speed up the recruitment of participants, the ICMR said in a statement on Saturday.
“The ICMR process is exactly in line with globally accepted standards for accelerating the development of vaccines for diseases with pandemic potential in which human and animal trials can continue in parallel,” the statement said. “Our tests will be carried out in accordance with best practice and rigor, and will be reviewed, if necessary.”
Bharat Biotech plans to enroll 375 people in the first phase of clinical trials and 750 people in the second phase, said an ICMR spokesperson. Approval of the vaccine for general use depends on the results of these trials, he said. A spokesperson for Bharat Biotech declined to comment on the August 15 calendar in the ICMR letter.
“They can’t do that,” said Jayaprakash Muliyil, chairman of the scientific advisory committee of the National Institute of Epidemiology, referring to the targeted schedule for the launch of the vaccine. Developing a vaccine is a complicated procedure that involves proving its effectiveness and safety, he said.
Although Bharat Biotech’s schedule is ambitious compared to other efforts, the mature Indian medical manufacturing sector and its large population, from which human trial volunteers can be easily found, are factors that could help to speed up the usual vaccine development process.
The trial will “most likely” begin by Monday, said C. Prabhakar Reddy, a professor at the Nizam Institute of Medical Sciences in Hyderabad – one of the test sites that received the ICMR letter. “We are all working day and night to meet the deadline but it will always be a neck-and-neck race,” he said, adding that he did not anticipate a shortage of volunteers “in the current scenario”.
A vaccine ready to be used by the public will allow the safe reopening of schools, offices and factories to revive the Indian economy, which is rushing to its first contraction in more than four decades. It will also be linked to autonomy – a motto that PM Modi has often repeated in recent weeks.
Developing countries are keen to reduce their dependence on other countries and on foreign drug manufacturers for vaccines. Called Covaxin, the “inactivated vaccine” candidate has demonstrated safety and the immune response in preclinical studies, said Bharat Biotech in a June 29 press release citing “the company’s track record in developing platform culture technologies Vero cell phone “.
He has developed vaccines against polio, rotavirus, Japanese encephalitis and Zika, the statement said.
Bharat Biotech “is working quickly to reach the goal, however, the end result will depend on the cooperation of all clinical trial sites involved in the project,” said the ICMR letter.
– With the help of Ari Altstedter.
