Oxford Vaccine
There was widespread concern last week when AstraZeneca and Oxford University announced on 8 September 2020 that they were pausing their vaccine trial after a potential serious side effect was reported in a UK volunteer. (1)
(For more background information on current vaccine trials around the world click here to read the piece “The race for a vaccine.”)
Although there has been media speculation as to the precise nature of the side effect there has been no official announcement. (2)
For reasons of patient confidentiality no details will be given to the press or public about any illnesses that occur in people on clinical trials. Half the volunteers in the trial are receiving a placebo vaccine so it is possible that this person has not even received the COVID-19 vaccine. The patient involved is expected to make a full recovery.
News that the trial had been paused emphasises why vaccine trials must remain meticulously thorough despite political pressures to develop a vaccine quickly. Pausing a trial is a routine and predictable event that allows researchers to analyse all the available safety data so far accrued and is a common occurrence in all drug and vaccine trials. Researchers are not just looking for adverse patient events in a trial, but also for their frequency and any trends or patterns.
The Oxford trial was resumed on 12 September 2020 after a review by an independent safety committee and UK Medicines and Healthcare Products Regulatory Agency announced it was safe to continue. (3)
Russian Vaccine
Forty scientists around the world have signed an open letter in response to the publication of data from Russian scientists in The Lancet claiming their vaccine is safe and effective. In the letter they draw attention to both the sparsity of data released but also discrepancies within that which has been published by the Russians. (4)
A spokesman for the Gamaleya National Research Centre for Epidemiology and Microbiology in Moscow has said it will not be responding to the letter. The Lancet has issued a statement saying that it “has invited the authors of the Russian vaccine study to respond to the questions raised in the open letter” but at the time of writing no replies have been forthcoming. (5)
