Why Pfizer’s Covid Vaccine Was Not Granted Approval In India For Emergency Usage

Earlier today (April 28), author Chetan Bhagat questioned the stance of the Indian government on not allowing authorisation for the emergency use of Pfizer’s Covid-19 vaccine in India, along with other foreign vaccines. In a series of tweets, Bhagat highlighted how over-dependence on domestic vaccines may have hindered the vaccination programme in India.

In December last year, the Central Drugs Standard Control Organisation or CDSCO was reviewing the emergency use approval sought by Pfizer.

As per the media reports then, one of the points of contention was the pricing of the vaccine. In the United States, where it had been granted approval, the vaccine carried a price tag of $20.

However, Indian stakeholders were also factoring in the pricing at which the AstraZeneca/Oxford vaccine was to be made available locally by the Serum Institute of India.

With the European Union, the pricing by Pfizer was negotiated at around $18. There was also the question of logistics, given the vaccine warranted storage at Antarctic temperature, thus posing an additional risk from a wastage viewpoint.

By early February this year, the CDSCO had decided to not recommend authorisation for the emergency use of Pfizer’s Covid-19 vaccine in India. The CDSCO’s Subject Expert Committee stated that cases of palsy and anaphylaxis had been reported and there were also investigations underway to understand the SAEs (Serious Adverse Events) after vaccine administration.

It was also reported that the firm had not proposed any plans or schedule to generate safety and immunogenicity data in the local population. Immunogenicity is defined as the ability of the vaccine candidate to generate the ideal immune response against the pathogen.

This was followed by Pfizer withdrawing its application for emergency use in India.

Pfizer was also in the news for other reasons recently.

As per recent media reports, the company was accused of bullying Latin American governments during the negotiations and also demanded sovereign assets like embassy buildings and military bases as a guarantee against the cost of any legal proceedings in the future. In Israel, authorities are investigating cases of heart inflammation after the administration of Pfizer’s vaccine.