It is more important than ever to monitor the safety of Covid-19 vaccines, even after they are licensed for us in the general public, the UK’s Drug Safety Research Unit (DSRU) has argued.
Vaccine
A paper published by DSRU in the British Medical Journal - Evidence Based Medicine argues that the speed of development for a Covid-19 vaccine are reasons why post-marketing surveillance needs to be conducted.
Usually, vaccines take around 10-12 years to be developed but researchers around the world have aimed to develop a Covid-19 vaccine within 12-18 months. The need for such a vaccine means that a candidate could be fast-tracked through the usual regulatory requirements and introduced to the population with limited clinical trial data, the paper states.
The researchers argue that in this scenario surveillance of the vaccine in the real world becomes even more paramount. Post-authorisation observational studies form an essential safety net by continuing to monitor the effectiveness and safety of a Covid-19 vaccine after it is licensed for use. Such studies are complementary to prelaunch clinical trials and not a replacement.
More so, the paper states that recent cases of illness and death seen in Covid-19 vaccine trials are indicative of the difficulties researchers face when developing new medicines.
The paper argues that premarketing studies for vaccines often don’t include a large enough sample size to detect rare adverse events, something which is less likely with expedited Covid-19 vaccine programmes. This is why vaccine monitoring in the postmarketing phase will require a much larger sample size of possibly several hundred thousand vaccinees, the DSRU says.