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Pharma wrap: Why ICMR's Aug 15 deadline for COVID-19 vaccine launch is controversial

Vaccine experts raised serious concerns, calling the timelines unprecendented and unrealistic.

July 06, 2020 / 12:40 PM IST

ICMR Director General Balram Bhargava's letter to 12 principal investigators instructing them to fast-track approvals to initiate clinical trials of Bharat Biotech's COVID-19 vaccine with an aim to launch by August 15, has caused a storm in the scientific community.

ICMR and Bharat Biotech are jointly working on the preclinical as well as clinical development of this vaccine.

It is not just the deadline, the tone and tenor of the letter that warned that non-compliance will be viewed very seriously, has sparked more controversy.

Vaccine experts raised serious concerns, calling the timelines unprecedented and unrealistic.

They pointed out that ICMR, in a rush to launch the vaccine, may end up compromising on safety and efficacy of the vaccine. Opposition parties wondered whether ICMR was acting as per scientific principles, or pandering to the whims of political bosses.


COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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ICMR has issued a press release, toning down its earlier stance, saying that the DG-ICMR letter to investigators of the clinical trial sites was meant to cut unnecessary red tape, without bypassing any necessary process and speed up recruitment of participants.

Also Read: ICMR says move to fast-track COVID-19 vaccine in accordance with global norms

"Just as red tape was not allowed to become a hindrance in the fast track approval of indigenous testing kits or for introducing in the Indian market potential COVID-19 related drugs, the indigenous vaccine development process has also been sought to be insulated from slow file movement. The aim is to complete these phases at the earliest, so that population based trials for efficacy could be initiated without delay," ICMR said.

To be sure, no one is questioning the intent of ICMR to speed up the trial and cut the red tape.

45-day timeline

But setting a timeline of less than 45 days, is something many found difficult to grasp. In normal times, it takes about 5-15 years to develop a vaccine, but due to urgency given the pandemic situation, the timelines are compressed. Most companies and countries are now talking about 15-18 months, much of that time is taken to test the vaccine on humans.

Also Read: COVID-19 vaccine | Britain nears 500 million pound deal with GSK, Sanofi

Even a 15-18-month timeline is a miracle, because it's a new virus, we have a very limited view of how long the vaccine protects us against COVID-19. We don't have definite answers how the vaccinated people would react to the next outbreak. Will the vaccine provide protection to high risk populations such as children and elderly people.

It is understandable that the government wants to give some hope to people. Announcing a launch date even before the vaccine is tested on first human for safety and efficacy, not only puts undue pressure on people working on the vaccine, but also creates a sense of false hope among public, making them complacent to throw winds to basic preventive measures such as social distancing, masking and personal hygiene.

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Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: Jul 5, 2020 02:11 pm
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