Within a year of the first confirmed case of the novel coronavirus in the U.S., the FDA authorised the Pfizer-BioNTech, Moderna COVID-19 — and later, the Johnson & Johnson vaccines — for emergency use, making the COVID-19 vaccines the fastest ever vaccines to be approved for widespread consumer use in history. Considering the timeline for vaccine production often takes upwards of fifteen years, the rapid development of a safe and effective COVID-19 vaccine is a marvel of scientific research and teamwork. While it is vital that such a preventive cure be adapted by Americans, it is important to be aware of the processes that brought us the vaccine so quickly. This article will highlight the legal implications and safety concerns involved with of accelerated COVID-19 vaccine development and approval, and outline issues facing the pharmaceutical industry with this and other types of vaccines.
The Vaccine Development Timeline, Compressed
Vaccines are biological products approved and regulated by the FDA’s Center for Biologics Evaluation and Research (CBER) under Section 351 of the Public Health Service Act (PHSA). Regardless of the timeline for production, vaccines must go through extensive testing before going on the market. Only vaccines that have been approved by the FDA can be used in the U.S. To be approved, the FDA must determine that the vaccine is safe, potent, and pure based on data from laboratory studies and clinical trials. The FDA licenses a vaccine only once it is proven safe and effective, and when its benefits outweigh the known risks.
“Medicine is clearly critical to the health of our families and communities”, shares Marie Napoli. “However, we have seen FDA-approved products be recalled for various reasons, including serious side effects, in the past. Research is ever-evolving, and it is important to stay informed about the possible health conditions that could develop from taking prescription medication.”
There are ways to accelerate certain stages of the vaccine development process. Drug companies can apply for the FDA to designate a biologic as a “Fast Track” product if it will treat or prevent a serious life-threatening illness and if no other alternative is available, and if laboratory, animal model, or human data is promising. The program gives drug developers more frequent meetings with the FDA to discuss the drug's development plan and ensure the collection of appropriate data needed to support drug approval. It also gives developers more frequent written communication about the design of the proposed clinical trials and the use of biomarkers.
Considering the timeline for vaccine production often takes upwards of fifteen years, the rapid development of a safe and effective COVID-19 vaccine is a marvel of scientific research and teamwork.
The FDA is sometimes able to approve a biologic before the intended clinical benefit is demonstrated. The Accelerated Approval (AA) Program gives the FDA authority to approve a biologic based on its effect on a “surrogate” endpoint that is reasonably likely to predict clinical benefit. For example, the clinical endpoint of a stroke medication might be that the patient has fewer or less severe strokes. Rather than measuring the incidence or severity of the patient’s strokes, which is time consuming, the medication may be measured for its effect on blood pressure, which is known to correlate strongly with stroke occurrence and severity. Upon receipt of Accelerated Approval, the drugmaker must conduct studies to verify and describe the drug’s benefit. If the studies cannot verify the benefit, the FDA may withdraw approval.
If a product is found to be defective or potentially harmful, a recall is the most effective way to remove it from the market. The FDA may request that a product be recalled, but the recall can be conducted by the company’s own initiative as well.
What if a Vaccine Causes Injury?
Serious adverse reactions to vaccines are rare. Unfortunately, a consumer cannot pursue personal injury or wrongful death litigation against vaccine manufacturers in the event of an injury. This is due to the National Childhood Vaccine Injury Act (NCVIA). Enacted in 1986, the NCVIA gives vaccine manufacturers the ability to continue their work without having to halt production due to lawsuits.
Although vaccine manufacturers are immune to lawsuits, financial compensation is possible for vaccine-related injury or wrongful death under the National Vaccine Injury Compensation Program (VICP). Anyone can file a claim. About 60% of all compensation by the VICP comes in the form of negotiated settlements, meaning compensation is still possible even if it cannot be proved whether the vaccine caused the injury.
To be approved, the FDA must determine that the vaccine is safe, potent, and pure based on data from laboratory studies and clinical trials.
“There are always avenues to pursue justice and I always ensure that every possibility is exhausted. Many times, monetary compensation is what comes to mind as the final result of a case,” says Napoli. “But I have been a litigator for many years, and I have to say that accountability, an answer and acknowledgement of wrongdoing can be just as important to a family who has lost a loved one.”
To increase transparency between vaccine manufacturers and consumers, mandated healthcare providers must report all adverse reactions to a vaccine to the Vaccine Adverse Event Reporting System (VAERS), a program run by the CDC and FDA. VAERS investigates adverse reactions to vaccines, using the gathered information as an early warning system to detect possible safety issues with vaccines. Considering that serious injury from vaccines is already unlikely, VAERS data further decreases the risk of unsafe vaccines reaching consumers.
In addition, the Vaccine Safety Datalink (VSD) monitors the safety of vaccines and conducts studies about rare and serious adverse events following immunisation. The VSD conducts safety studies based on questions and concerns about immunisations that arise from VAERS data and medical literature.
Special Considerations for the COVID-19 Vaccine
COVID-19 vaccines are considered a countermeasure to a pandemic. A countermeasure is a vaccination, medication, device, or other item recommended to diagnose, prevent or treat a declared pandemic, epidemic or security threat. Injury from countermeasures is covered by a separate program, the Countermeasures Injury Compensation Program (CICP). The CICP is a program of the Public Readiness and Emergency Preparedness Act (PREP Act), which authorises the CICP to provide benefits to certain individuals or estates of individuals who sustain a covered serious physical injury as the direct result of the administration or use of covered countermeasures identified in and administered or used under a PREP Act declaration. The CICP also may provide benefits to certain survivors of individuals who die as a direct result of the administration or use of such covered countermeasures.
Protecting Consumers from Harmful Drugs
The rapid development and deployment of the COVID-19 vaccine raise the question of whether the FDA is cutting corners in its approval process for other new drugs. Research has shown that over the past four decades, the FDA has approved drugs increasingly fast based on increasingly weak evidence. This includes approving drugs based on only one pivotal clinical study as opposed to two or more, and increased reliance on data from surrogate endpoints instead of intended clinical benefit. This means it is possible that new drugs will not be substantially better than previous ones. Relying on surrogate endpoints may take the focus away from achieving the clinical benefit. For instance, the surrogate endpoint of a cancer drug shrinking tumours may not lead to the clinical benefit of improved survival rates after treatment. Hasty approval based on weak evidence inevitably means a higher likelihood of product recalls. Requiring higher standards for approval of drugs will decrease the number of harmful drugs that reach consumers.
The COVID-19 vaccine is vital to ending the pandemic and returning life back to normal. Apprehension toward getting vaccinated is understandable considering that it is a brand-new vaccine, but medical and scientific evidence affirms that the benefits of vaccines outweigh the risks. Serious adverse reactions to vaccines are rare, and the approved COVID-19 vaccines (and the dozens of ones currently in clinical trials) are going through stringent testing. Consumers can find comfort in knowing that options for compensation are available to them in the unlikely event of injury, and that there are various systems in place to record adverse reactions to vaccines to prevent widespread harm.
“Knowing the devastating effects defective drugs and medical devices can have on someone only strengthens my resolve to represent those victims”, states Napoli.
Marie has been an attorney for over twenty-five years. She has experience handling personal injury, medical malpractice litigation, pharmaceutical litigation, employment discrimination, civil rights, and mass tort matters. Marie earned her J.D. from St. John’s University Law School and her L.L.M. degree from New York University (NYU) School of Law. She has worked for the New York Appellate Division, 2nd Department and has taught CLE courses on Tort and Civil Procedure at St. John’s University School of Law. As a founding partner of Napoli Shkolnik PLLC, Marie is involved in many depositions and has tried multiple cases to verdict. As a skilled and determined attorney who is well-versed in numerous litigation fields, Marie understands the breadth of the legal issues that particularly affect women injured by pharmaceutical and other defective products.
