The next generation of pharmacovigilance

Robert T Chen, MD MA

Historically, much of the safety assessment of a new vaccine was deferred to post-introduction. Safety assessments within pre-approval clinical trials tended to be separate from post-approval Real-World evidence (RWE). There were barriers to implementing a vaccine lifecycle approach, including a disconnect between separate teams and staff for pre- versus post-approval. Applicability in low- and middle-income countries (LMICs) and high-income countries (HICs) was also limited. In fact, LMICs were often missing large administrative datasets.

Do COVID vaccines prevent long COVID: Beyond the 3-months mark?

Helen Petousis-Harris, BSc, PGDipSci (Dist), PhD

One of the most perplexing health challenges associated with the COVID-19 pandemic is the enigmatic condition known as long COVID. As the name suggests, it refers to a multitude of symptoms and conditions that persist beyond three-months after someone has been infected with the virus. These symptoms cannot be explained by other diagnoses, making it a puzzle that continues to baffle researchers and healthcare professionals alike.

Provocative headlines on a post-COVID vaccination syndrome

Helen Petousis-Harris, BSc, PGDipSci (Dist), PhD

Vaccines authorised for use are incredibly safe, but the risk for serious side effects is not ‘0’. Vaccine safety scientists exist because vaccines are not 100% safe. Just to be clear, nothing in the multi-verse is 100% safe but vaccines can come pretty close. The risks of COVID-19 disease are far greater than risks posed by the vaccines.