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2nd Vaccine Clinical Trial Paused After Participant Becomes Ill

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

Johnson & Johnson’s clinical trial concerning a COVID-19 vaccine has been paused after one of the trial participants became ill.

The news comes just a month after drugmaker AstraZeneca announced that it was pausing its COVID-19 vaccine trial due to an unspecified illness in a study participant. The company’s CEO later reportedly said in a phone call with investors that the patient was experiencing symptoms related to a rare neurological disorder.

J&J’s press release announcing the pause attempted to paint a business as usual picture but the pause underlies the essential fact about vaccines-they are trial and error and can have unexpected side effects.

“Adverse events — illnesses, accidents, etc., even those that are serious, are an expected part of any clinical study, especially large studies,” the company said in the press release, adding that there will be a “careful review of all of the medical information before deciding whether to restart the study.”

As I wrote on our website, “While the majority of vaccinated people should greatly benefit from the vaccine, it is inevitable that a slim percentage of people will experience serious side effects from the vaccination regimen and the drugs used in it*. Others may be peculiar to the specific vaccine being administered, such as the appearance of Guillain Barre Syndrome in the swine flu program of 1976.”

Under the federal Public Readiness and Emergency Preparedness (PREP) Act, the manufacturers and other parties in the chain of distribution and administration of vaccines are immunized from being sued for harm suffered by patients in most cases. Typically, willful misconduct must be present to warrant a lawsuit against these parties. Regarding the pending COVID-19 vaccines, the U.S. government has announced that it will stand in place of vaccine manufacturers and distributors, essentially representing them in legal situations while also gaining lawsuit immunity through PREP.

Under normal circumstances, the development of a relatively safe vaccine takes years. This vaccine is being rushed to stop the continued health issues caused by the coronavirus. While understandable, rushing to market an unproven or hastily tested vaccine may lead to further problems that become worse than the original virus.

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