Pfizer withdraws EUA application for its Covid vaccine in India after government requests domestic safety trials

03/03/2022 / By Ramon Tomey

Vaccine manufacturer Pfizer last month withdrew the emergency use authorization (EUA) application for its Wuhan coronavirus (COVID-19) vaccine in India. The New York-based firm’s withdrawal followed its refusal to conduct a domestic safety trial for its vaccine, which India’s drug regulator required.

Pfizer decided to rescind its EUA application in India during a Feb. 2 meeting with the Central Drugs Standard Control Organization (CDSCO), the country’s regulatory agency. CDSCO ordered the pharmaceutical giant to conduct a local trial in India “to determine if the vaccine is safe and generates an adequate immune response in citizens.”

According to the regulator, the trial is a prerequisite before an EUA can be granted to Pfizer’s BNT162b2 vaccine – made in partnership with German company BioNTech.

Dr. Vinod K. Paul, the head of India’s National Expert Group on Vaccine Administration for COVID-19, said a “bridging trial” for foreign vaccines such as the one from Pfizer is needed before receiving approval. He explained that bridging trials are important as they serve to determine how safe and effective are the vaccines when injected into populations with a different genetic makeup than that of Western nations.

Pfizer applied for an exemption from this bridging trial. It cited evidence of EUA approvals BNT162b2 received in other countries, which were based on clinical trials conducted in the U.S. and Germany. Despite the presence of provisions that allow vaccine bridging trials to be waived in certain circumstances, CDSCO opted not to grant Pfizer an exemption.

The regulator pointed out serious adverse effects linked to the Pfizer COVID-19 vaccine, adding that “the causality of [these] events with the vaccine is being investigated.” It continued: “The firm has not proposed any plan to generate safety and immunogenicity data in [the] Indian population. After detailed deliberation, [CDSCO] has not recommended for grant of permission for emergency use [of the Pfizer vaccine] in the country at this stage.” (Related: Beloved doctor in India succumbs to coronavirus despite being fully vaccinated.)

Pfizer vaccine out, other vaccines in

Aside from the serious adverse effects linked to the vaccine and Pfizer’s refusal to conduct a local vaccine trial, India also deemed the BNT162b2 vaccine as unsuitable for the country due to its stringent temperature requirement.

Officials from the Indian Ministry of Health and Family Welfare said the Pfizer COVID-19 vaccine is not the best choice for the country. It requires a storage temperature of -70 degrees Celsius (-94 degrees Fahrenheit) – which only expensive freezers are capable of. Such freezers are not readily available in India.

Pfizer confirmed the move to rescind its EUA application in a statement to Reuters. “Based on the deliberations at the meeting and our understanding of additional information that the [Indian drug] regulator may need, the company has decided to withdraw its application at this time. Pfizer will continue to engage with the authority and re-submit its approval request with additional information as it becomes available in the near future.”

The drug manufacturer originally sought authorization for the BNT162b2 vaccine in India in late 2021. The Indian government approved the EUA applications for two subsequent vaccine candidates: the CoviShield shot made by AstraZeneca and the University of Oxford, and the homegrown vaccine candidate Covaxin by Bharat Biotech and the Indian Council of Medical Research.

Another homegrown vaccine maker joined the list of potential COVID-19 vaccine candidates. Dr. Reddy’s Laboratories has been conducting a bridging trial for a local version of the Russian Sputnik V shot, dubbed as Sputnik Light. The company, based in the Indian state of Telangana, is in charge of manufacturing the single-dose vaccine, with approval for emergency use in the works.