Liability for Covid vaccine injuries in the face of windfall profits

By Anil Madan

Last week was abuzz with media reports about a confrontation between Pfizer CEO, Albert Bourla, and two journalists in Davos, Switzerland. They peppered Bourla with questions about why he had not disclosed that the Pfizer vaccine does not prevent transmission of the virus, about the vaccine’s effectiveness, whether he is concerned about product liability (for vaccine injuries), and how much he personally made off the vaccine. The questions conflated the issues of vaccine effectiveness with preventing transmission or retransmission of the virus. The other questions raise some interesting issues, but certainly, the encounter between the reporters and Bourla has been blown out of proportion.

At one point, Bourla was asked: “You (Pfizer) said it (the vaccine) was 100 per cent effective, then 90 per cent, then 80 per cent, then 70 per cent, but we now know that the vaccines do not stop transmission. Why do you keep that secret?” Readers curious about the encounter can view the video here and look up the profiles of the reporters on the Internet.

Vaccine Effectiveness and Preventing Transmission of the Virus

It goes without saying that Covid vaccines have been immensely effective in curtailing the severity of illness associated with infections and in reducing mortality dramatically. The experiences of the US, Britain, India, Europe, Japan, South Korea, etc., are testimony to this. A study reported in Lancet, the British journal estimated that vaccines had saved between 14 and 20 million deaths.Underscoring this is China’s experience where Chinese vaccines were ineffective, and the lifting of draconian lockdowns and quarantine rules has, according to reports, led to a surge of infections and deaths.

The effectiveness of a vaccine in preventing infection, mitigating the effects of an infection, or in preventing death, do not necessarily tell us whether the vaccine prevents the transmission of the virus. We need first to dismiss the myth that vaccines are ineffective if one can be infected despite being vaccinated. If this were the case, every first shot of a multi-shot vaccine would be deemed ineffective. Moreover, vaccines are not 100% effective. The premise on which a vaccine works is that it enables a vaccinated person to generate antibodies to fight off the infection if that person is attacked by the virus.

There is nothing new here. Anika Singanayagam, academic clinical lecturer in adult infectious disease at Imperial College London, is quoted in a year-old BMJ article: “The main point of vaccines is not to do with preventing transmission. The main reasons for vaccines for Covid-19 is to prevent illness and death.” Therefore, it is not unexpected that it is still possible to pass on the virus while vaccinated. Adding to the complexity is that Omicron variants are more transmissible than the original covid virus.

She added: “There are avenues to think about the development of vaccines that can have more of an effect on transmission. Those are usually vaccines delivered more locally, such as directly through the respiratory tract, which could tackle the source of major transmission, rather than the lungs, which is where the first generation of vaccines was targeted in order to prevent severe infection. That’s probably the way things will move in the future.”

Immunity from Liability for Vaccine Manufacturers

In a story covering the encounter with Bourla, The Times of India reported that in the early days of the vaccination drive, Pfizer sought an indemnity bond that would exempt it from legal claims arising from adverse effects of the vaccine. India’s minister for state for Information and Technology is quoted as having chimed in with a tweet: “Just to remind all Indians that Pfizer tried to bully Govt of India into accepting conditions of indemnity.” This surely exaggerates the situation.

As is well documented, India relied entirely on the AstraZeneca vaccine produced under license by Serum Institute of India under the name Covishield and Covaxin produced by Bharat Biotech. Since then, the Sputnik V vaccine as well as the Moderna mRNA vaccine, and the Johnson & Johnson vaccine have been produced in India. Indeed, in September 2021, India’s government announced that it would not buy Covid-19 shots from Pfizer and Moderna mainly because the domestic output of more affordable and easier-to-store vaccines had increased dramatically.

And, if Pfizer did ask for indemnity, that should be no surprise in view of the history of vaccine injury laws in the US. In 1955, about 200 people who received the polio vaccine in the US were paralyzed. In the Cutter case, the California Supreme Court upheld a jury verdict for the plaintiff, finding a vaccine manufacturer strictly liable for injury. In the 1970s and 80s, suits for vaccine injuries increased dramatically and soon, pharma companies abandoned the vaccine business. In 1986, Congress passed the National Childhood Vaccine Injury Act (NCVIA) to address the situation. Not all vaccines are covered under the act and some adult vaccines are covered.

Under the act, a person claiming a vaccine injury from a covered vaccine cannot sue a vaccine manufacturer without first filing a claim with the US Court of Federal Claims. Certain side-effects are presumed to be caused by the vaccination. Claims are paid based on a formula. If a claim is denied, or if the claimant is not satisfied with the compensation, only then may lawsuit for damages be filed.

Vaccine manufacturers pay an excise tax per dose to the US Treasury to fund the NVICP. Through 2023, almost $5 billion in awards have been paid and an additional $56 million awarded in attorney fees. Even unsuccessful claimants are eligible to recover counsel fees for claims brought in good faith and on a reasonable basis.

Of course, this compensation is nowhere near what successful claimants might recover through regular tort actions in court. But the right to pursue such suits is preserved.

It should also be noted that at the height of the pandemic Congress passed an emergency law under which except for willful misconduct, a covered person is immune from lawsuits and liability under federal and state law with respect to all claims for loss resulting from the administration or use of a covered countermeasure, such as a Covid-19 vaccine.

Bourla Compensation and Pfizer profits

Bourla has received total compensation of approximately $70 million for the three years 2020-2022. This is not surprising in view of Pfizer’s revenues of over $100 billion for Covid-related vaccines and drugs such as Paxlovid. The company projects revenue of $100 billion for 2023.

Pfizer plans to increase the cost of its vaccine from approximately $20 per dose charged during the height of the pandemic to governments, to over $130 per dose and is planning on recommending an annual shot. Pfizer’s cost per dose is said to be $1.18 but this does not include the costs of transporting the vaccine under stringent cold chain storage requirements. Nevertheless, the price increase reeks of gouging and opportunism.

Although the questions about whether Pfizer’s vaccine and, indeed other vaccines, prevent transmission of the virus were scientifically unsound, it appears that with more focused efforts, vaccines that are better designed to prevent transmission are possible. Certainly, Pfizer and by extension Moderna, have generated enough profits to commit resources to such an effort.

The goal should be to compensate adequately and fully, all those who suffer from vaccine injuries. Vaccine liability laws allow manufacturers to reap profits without accountability beyond a low excise tax. An ideal law would tax the profits of vaccine manufacturers sufficiently to ensure just compensation and the development of safer vaccines.

Cheerz…
Bwana


Mauritius Times ePaper Friday 27 January 2023

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