Race For Covid Vaccine Delivery Heats In India With Pfizer, And Serum Applied For Emergency Use Authorization

If approved, the vaccine rollout may start by February – March 2021.

The race for vaccine COVID-19 vaccine delivery heats up in India with global drug maker Pfizer Inc. and the world's largest vaccine maker by volume, the Serum Institute of India (SII) applying for emergency use authorization of the vaccine in India and expects the vaccine rollout before March 2021.



Pfizer Limited, the Indian arm of the US pharmaceutical major, has become the first firm to seek from the Drugs Controller General of India (DCGI) an emergency use authorization for its Covid-19 vaccine in the country after its parent company secured such clearance in the UK and Bahrain.

In its application submitted to the drug regulator on December 4, Pfizer has sought permission to import the vaccine for sale and distribution in the country, besides waiver of clinical trials on the Indian population under the New Drugs' special provisions and Clinical Trials Rules, 2019.

When asked for comments, a Pfizer spokesperson in an email reply to a query by ABP News said, "Pfizer is dedicated to ensuring the availability of this vaccine for use by Governments across the world. During this pandemic phase, Pfizer will supply this vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorization or approval. We remain committed to engaging with the Government of India and explore opportunities to make this vaccine available for use in the country."

SII had also sought emergency use authorization in the country for AstraZeneca Plc's COVID-19 vaccine.

Confirming the development, Adar Poonawala, CEO SII, on Monday, tweeted, "As promised, before the end of 2020, Serum Institute of India has applied for emergency use authorization for the first made-in-India vaccine, COVISHIELD. This will save countless lives, and I thank the Government of India and Narendra Modi Ji for their invaluable support."

SII is developing the vaccine in collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine in India is learned to have already manufactured 40 million doses of the vaccine under the at-risk manufacturing and stockpiling license it obtained from the DCGI.

After visiting the institute's facility in Pune on November 28 to review vaccine development, PM Narendra Modi tweeted, "Had a good interaction with the team at Serum Institute of India. They shared details about their progress so far on how they plan to further ramp up vaccine manufacturing. Also took a look at their manufacturing facility."

Pfizer has developed the vaccine with German BioNTech, relying on novel technology called messenger RNA, claimed that the vaccine was 95% effective in a final analysis of clinical-trial data.

AstraZeneca Plc's COVID-19 vaccine is facing queries from scientists over its trial data, which showed a 1.5 dose regimen delivered more than 90% efficacy and a full two-dose regimen just 62%, both administered over two stages.

SII vaccine named 'Covishield' is said to be India's main hope of large-scale supplies as it can be stored in 2 Celsius to 8 Celsius, unlike Pfizer's vaccine that needs to be stored and transported at -70 degrees.

Many experts have expressed concern over the logistical issue linked to the Pfizer vaccine distribution, which has not conducted trials on the country's local population.



When asked about logistical challenges, a Pfizer spokesperson said, "We have experience working with customers in all markets to help ensure success. We have developed detailed logistical plans and tools to support effective vaccine transport, storage, and temperature monitoring. Globally, we will be utilizing road and air modes of transportation via our main carrier partners. We have also developed packaging and storage innovations to be fit for purpose for the range of locations around the globe where we believe vaccinations will take place."