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Roche seeks emergency use approval of antibody cocktail to treat COVID-19 patients

The company on Wednesday said that it is also working urgently to increase manufacturing capacity and supply by ramping up our own production network, as well as actively collaborating with external partners to maximize production of Actemra (Tocilizumab) wherever possible with the goal of increasing its availability.

April 28, 2021 / 07:47 PM IST

Swiss drug maker Roche Pharma said it is working with the Indian drug regulator to accelerate an emergency use authorization (EUA) for its investigational antibody cocktail Casirivimab and Imdevimab in India, based on the data that have been filed for the emergency use authorisation (EUA) in the US and the CHMP scientific opinion in the EU.

"An emergency use authorization in India would enable the import of globally manufactured product batches to India as soon as possible," Roche said.

Neutralizing antibody cocktails may play a role in the fight against COVID-19, in treatment of high-risk patients before their condition worsens.

Capacity expansion of Tocilizumab

The company on Wednesday said that it is also working urgently to increase manufacturing capacity and supply by ramping up our own production network, as well as actively collaborating with external partners to maximize production of Actemra (Tocilizumab) wherever possible with the goal of increasing its availability.

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COVID-19 Vaccine

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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 have observed an unprecedented demand for Tocilizumab (Brand: Actemra) given the significant increase in Covid cases across India in the last few weeks," Roche said in a statement.

"We are responding to this situation with supplies over this and the coming weeks to meet the immediate emergency demand. However, we are mindful that the current unprecedented demand may far exceed the supplies we can provide at this moment," Roche said.

Tocilizumab is considered for patients with moderate disease with progressively increasing oxygen requirements and in mechanically ventilated patients not improving despite use of steroids.

The drug, which has to be taken in two doses, is manufactured by Roche and imported and distributed by its partner Cipla in India.

The drug went out of stock in the country a few weeks ago due to a sudden surge in its demand because of a sharp rise in COVID-19 cases in the country in this month.
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: Apr 28, 2021 07:40 pm

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