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COVID-19 Vaccines | Biological E to begin producing 75-80 million doses of vaccine candidate from August 2021

The company is also starting Phase III trials of its recombinant protein vaccine candidate from August.

May 07, 2021 / 02:50 PM IST
Mahima Datla, MD of Biological E is confident that they will be able to come out of the gate running with 75-80 million doses per month “right from the start”. (Image Source: Shutterstock)

Mahima Datla, MD of Biological E is confident that they will be able to come out of the gate running with 75-80 million doses per month “right from the start”. (Image Source: Shutterstock)

Vaccine manufacturer Biological E is “gearing up” to produce 75-80 million doses per month of its recombinant protein vaccine candidate from August 2021, the Times of India reported.

The pharma company also said its vaccine will be “one of the most affordable” options in India.

Mahima Datla, MD of Biological E told the paper that while she is “not at liberty to share” details of pricing as it is still being worked out, “I can assure you it will be among the most affordable Covid-19 vaccines that you can get a hold of.”

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She further sought to assure that the company “will not take advantage of the situation”.

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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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“We are third generation in this business. COVID-19 did not make us enter into this business and we pride ourselves on having made vaccines accessible in pre-pandemic times to countries that needed it the most,” she added.

The company has also signed to produce 600 million doses of Johnson & Johnson’s single jab COVID-19 vaccine in India.

Datla’s assurance comes at a time when India is grappling with a raging second wave of the coronavirus pandemic has caused cases to skyrocketed, claimed many lives and debilitated the country’s healthcare system.

Further, Russia on May 6 announced emergency use of its single-shot jab Sputnik Light that will be manufactured in India among other countries. If Biological E’s plans and its candidate vaccine is approved soon, it would bolster India’s vaccines list that currently has three vaccines – Serum Institute’s Covishield, Bharat Biotech’s Covaxin and Russia’s two-dose Sputnik V (produced by Dr Reddy’s) and ease shortage across healthcare facilities.

Datla was confident that they will be able to come out of the gate running with 75-80 million doses per month “right from the start”.

Check here for the latest updates on all COVID-19 vaccines

“It is a significant capacity and we have already scaled up. We have confidence in our manufacturing capabilities to be able to deliver that number from August onwards. We are well-resourced in terms of capacities, both for fill-finish and bulk antigen. We are focusing on hunkering down and getting our vaccines through to the finish line and making sure that we're able to deliver capacities...” she added.

Notably, Biological E has been promised funding for at least 1 billion doses by 2022-end from the US International Development Finance Corporation under the Quad initiative. The company is also preparing Phase III trials on 1,268 healthy volunteers aged 18-80 at 15 centres as part of its global study. The trials will begin from August 2021, Reuters reported.

The cost will also be an important factor for India. Dr Maria Elena Bottazi, associate dean, National School of Tropical Medicine (NSTM) at Texas’s Baylor College of Medicine, which is collaborating with Biological E on the candidate vaccine said it would be cheaper to produce at $1.5/dose (approx. Rs 110/dose) as it is modelled after the existing hepatitis B vaccine.

Pricing of vaccines in India has seen much discourse with the Centre initially offering jabs to the elderly for free. However, in the third phase from May 1, states were asked to bear costs for jabs of citizens in the 18-45 age group.

The Supreme Court taking suo moto cognizance of multiple issues with regards to the COVID-19 situation in India has also asked the Centre to reconsider dual pricing structure.

At present the Centre and state governments are offering vaccines for free at state-run facilities, but private hospitals are charging between Rs 900-1,600 per jab. Also many states, such as Maharashtra, have opened only limited vaccination slots for 18-45 age group.

Follow our full COVID-19 coverage here
Moneycontrol News
first published: May 7, 2021 02:50 pm

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