As the development of vaccines against Covid-19 is progressing, the question becomes urgent who will be liable if a vaccine causes unexpected adverse effects?
The question assumes significance in the wake of Adar Poonawalla announcement that the Covid vaccine makers would make a proposal to the government to provide protections to them against all forms of lawsuits for their vaccines especially during a pandemic.
This has started a debate whether coronavirus vaccine makers should be shielded from liability or not?
Regardless of proper design, manufacture, and delivery- it is commonly accepted that vaccines are not without risks. Although serious adverse events are rare, but some types of Adverse events may occur during the clinical trials.
As the US began vaccination early this week, some cases of allergic reactions were reported. But in the US, vaccine makers have got the protection from any lawsuits.
The US government has given companies like Pfizer and Moderna ‘immunity’ from liability if something unintentionally goes wrong with their vaccines, CNBC reported.
Why the American government gave total immunity to Pfizer and Moderna from liability?
The coronavirus vaccines have been manufactured in record time, and the process of vaccine that takes at least five years or more normally was stepped up and completed in less than a year.
Had it gone through the normal process, it would not have reached reach the market until mid-2021.
“When the government said, ‘We want you to develop this four or five times faster than you normally do,’ most likely the manufacturers said to the government, ‘We want you, the government, to protect us from multimillion-dollar lawsuits,’” Rogge Dunn, a Dallas labor and employment attorney was quoted as saying by the CNBC.
Should India Protect Vaccine Makers Against Lawsuits?
For a vaccine that will most likely be distributed worldwide, there is an inevitable risk of serious adverse events, such as seizures and allergic reactions, even with a very safe product. Such events might not begin surfacing until a substantial number of people have been vaccinated.
Most countries are offering Pharmaceutical companies complete immunity from lawsuits but some governments will refuse to make such offers as manufacturers should pay for the side effects their vaccine cause.
Poonawalla, who made the comments during a virtual panel discussion on the challenges to vaccine development said that the vaccine makers were going to propose this idea of have protection against all lawsuits for their vaccines.
“We need to have the government indemnify manufacturers, especially vaccine manufacturers, and against all lawsuits. In fact, COVAX and other countries have already started talking about that,” Poonawalla said.
Adar Poonawalla’s comments came weeks after a 40-year-old man who took part in the ‘Covishield’ vaccine trial in Chennai had leveled against the company, alleging serious side effects, including a virtual neurological breakdown and impairment of cognitive functions.
The participant claimed neurological and psychological issues as a result of taking the coronavirus vaccine dose and demanded, the testing, manufacturing, and distribution of experimental coronavirus vaccine ‘Covishield’ be halted immediately.
Refuting the charges, Serum had said, “It is evident that the intention behind spreading such malicious information is an oblique pecuniary motive.
“..the government can act, the US, for example, has in fact invoked a law, to say that during a pandemic, and this is especially important only during a pandemic, to indemnify vaccine manufacturers against lawsuits for severe adverse effects or any other frivolous claims which may come about because that adds to the fear and also will bankrupt vaccine manufacturers or distract them if they have to just all-day fight lawsuits and explain to the media what is happening,” Poonawalla said.
