The global pharma giant Pfizer has recently said that it has offered the Indian government not-of-profit pricing, which it claims to be the cheapest price for the COVID vaccine that it has developed.
Recently, the Indian government, through its drug regulator, has not granted approval for Pfizer’s COVID vaccine, under emergency use authorization in India. This prompted Pfizer to withdraw its request for approval.
One of the reasons that the Indian regulators have cited for not granting the emergency use authorization to the Pfizer vaccine is the concerns over a few serious adverse events or side effects, for which additional data was needed by the drug regulator, but was not provided by Pfizer.
Some of these side effects include incidents of Palsy anaphylaxis, and blood clots that were caused after the administration of the Pfizer vaccines in countries where the vaccine is approved for use. In fact, there have been some deaths as well after the administration of the Pfizer vaccine, which haven’t been fully investigated, as of yet.
Why was the Pfizer COVID vaccine Not approved in India?
But the main reason that authorities have cited for not granting Pfizer, the emergency authorization in India is the unwillingness of the pharma giant to do bridge trials for generating safety and immunogenicity data in the Indian population.
Indian Drug regulator has been evaluating with great detail, the Phase One, two, and three trial data of potential COVID vaccines that have applied for approval in the Indian market. The Drug Controller General of India, or the DGCI, as it is known has set certain standards that are applicable to both the foreign and Indian COVID vaccine manufacturers.
These conditions or standards have to be met for any authorization to sell these vaccines in the Indian market. Big Pharma companies do not have a great reputation when it comes to ethical and moral behavior regarding drug pricing and liabilities.
Pfizer is accused of very high-level bullying by two Latin American countries.
Recently the same pharma company Pfizer was accused of bullying 2 Latin American countries.
The Bureau of Investigative Journalism, in a report that it published with the STAT, has brought to the fore “very high-level bullying” by Pfizer while negotiating with these countries.
During the COVID vaccine negotiations. Drug and pharma giant Pfizer allegedly had asked the governments of Argentina and Brazil to put up its sovereign assets, including military bases and federal bank reserves, as collateral to protect itself against the civil lawsuits that the citizens of these countries might file against Pfizer COVID vaccine.
Although it’s a norm for most countries to offer indemnity to the vaccine manufacturers in situations like pandemics, the officials of these two Latin countries, felt that Pfizer’s demands were not justified and accused the pharma giant Pfizer of bullying, and putting pressure on the governments of these countries.
Pfizer asked the governments of Argentina and Brazil, for liability protection, not only against the civil liability claims of its citizens who may suffer adverse reactions from the vaccine, but it wanted indemnity for even cases, in which the harm was caused due to Pfizer’s own negligence, fraud, or malice.
The Big Pharma lobby around the world has often been accused of treating developing countries, especially third-world countries, unfairly and using bullying and unfair means to gain drug approvals.
India, on its part, has decided that such terms and conditions or applications from big pharma companies that are manufacturing COVID vaccines will not be accepted until they meet the minimum standards prescribed by the Indian drug regulator, the DGCI.
For any foreign vaccine manufacturer to get emergency use authorization or any future authorization for their vaccines, it is imperative to conduct a bridging trial in India. In the absence of this study, any drug or vaccine will not be approved in India.
Since the rejection of Pfizer by the Indian government, Pfizer has been lobbying through celebrities, other paid media channels, and global think tanks against the Indian government’s decision.
The big pharma companies are trying to use the current spike of COVID cases in India to vilify the Indian government and its prime minister, Narendra Modi, expecting that there will be a public hue and cry, that will force the Indian government to reconsider its decision.