Those who wish to receive the emergency meningitis vaccine that the University is offering will not have to waive any rights before receiving it.
Consent forms were made available over Thanksgiving break on the University’s website and emailed to underage students in order to be signed by their parents. The content of the forms is identical for both overage and underage students except for the sections pertaining to the signee and recipient.
The vaccine, called Bexsero and made by Swiss company Novartis, is being offered by the University in an attempt to curb an outbreak of meningitis type B on campus. Currently, students are required by state law to receive a licensed meningococcal vaccine, but the vaccines licensed in the U.S. only cover types A, C, Y and W-135, not B, the type responsible for the current outbreak. Bexsero has been approved for use in the European Union and in Australia.
The consent form, which has to be signed and handed in before receiving the vaccine, does not ask students to waive their right to sue the University, the Centers for Disease Control and Prevention or the manufacturer of the vaccine, Novartis, in case of harm caused by the vaccine.
In addition, if any harm is done as a result of the vaccine, students may be eligible for compensation under the National Vaccine Injury Compensation Program, a federal program that deals with claims of injury relating to vaccines.
Through the VICP, students may be able to receive compensation for harm caused by the vaccine, depending on how long after vaccination symptoms or side effects emerge.
According to the form, possible side effects include headache, nausea, bruising and muscle and joint pain. These side effects occur in more than one out of every 10 people, the form says. More serious side effects, which occur in fewer than one out of every 100,000 people, include severe allergic reaction and anaphylactic shock.
According to CDC Health Communications Specialist Jason McDonald, it is standard procedure for vaccine consent forms not to ask recipients to waive their rights, and it is also standard procedure to offer recourse and potential compensation through VICP.
Peter McDonough, general counsel for the University, declined to comment on the consent form on Monday, citing a busy schedule.
But according to Leslie Gerwin, a former health law and policy professor and the associate director of the Program in Law and Public Affairs, it is unusual for Food & Drug Administration consent forms to allow recipients of a vaccine to retain their right to sue.
For FDA-approved drugs, Gerwin said, consent forms generally require signees to agree that they will not hold the institution administering the vaccine liable for possible harms, she said.
The FDA has worked with the CDC to approve Bexsero as a “treatment investigational new drug,” which, according to the FDA’s website, is a drug or vaccine “showing promise in clinical testing for serious or immediately life-threatening conditions.”
Bexsero has not yet been approved by the FDA, so the procedure for obtaining consent is different, Gerwin explained.
“You’re not explicitly waiving anything,” she noted. “Princeton is not giving you the vaccine. It’s only recommending that you take it … although it is benefiting from your taking it.”
The CDC is a government agency with sovereign immunity and, as such, is not liable for any harm caused by the vaccine, according to Gerwin. Sovereign immunity is a legal concept that holds that neither the state, nor those acting as agents of the state, may be sued for acts within the scope of their responsibility.
“Generally, the primary responsibility rests with the drug company,” Gerwin said, explaining that students could potentially sue Novartis in case of harm. “Since you’re not waiving any rights, you’re not waiving the negligence of the company.”
Gerwin said in a Nov. 25 interview that the consent form, which had not yet been released, would likely have few legal ramifications for the University.
Per standard operating procedure, the CDC will release a list of Bexsero’s possible side effects and a timeline predicting when such side effects could occur once more data is gathered, Gerwin said. If those injected with the vaccine develop the listed side effects within the given time period, they may be eligible for compensation, she added.
The University and the CDC decided to administer the non-FDA approved vaccine in November. There will be two doses, one of which will be administered in December and the other in February.