RIO DE JANEIRO, BRAZIL – After the administration of doses in volunteers initiated on October 9th, Johnson & Johnson announced the interruption of its trials in Brazil on Tuesday, October 13th. The pause was triggered by a serious adverse reaction detected in a trial subject. In all, twelve volunteers were administered the drug in Brazil.
While the work of Janssen-Cilag – Johnson & Johnson’s pharmaceutical arm – is interrupted, ten other Covid-19 vaccines are currently undergoing their final trial stages, the so-called Phase III clinical trials. The laboratories include Moderna, Pfizer and BioNTech, CanSino Biologics, the Gamaleya Research Institute, AstraZeneca, Novavax, the Wuhan Biological Products Institute, Sinopharm, Sinovac Biotech and the Murdoch Children’s Research Institute. Of these, three have been approved to conduct trials in Brazil: AstraZeneca, Sinovac Biotech and Pfizer. In all 25,000 Brazilian volunteers should take part in the scientific efforts, through an authorization granted by National Health Regulatory Agency (ANVISA).
The fact that a vaccine is currently in Phase III is not indicative of imminent approval. Many trials fail in this final stretch. Nevertheless, São Paulo governor João Doria is confident that the Sinovac vaccine will be distributed in the country before the end of 2020. The few side effects presented by Chinese vaccine volunteers so far contribute to the governor’s optimism. Manufacturers such as Astrazeneca and Pfizer expect to complete the trials of their vaccines later this year.
Another 29 trials are currently in Phase I and 14 in Phase II. Laboratory trials without the involvement of humans – i.e., pre-clinical trials – amount to 92.
The most advanced in Brazil are the Oxford vaccines (with the Astrazeneca laboratory) and the Sinovac Biotech – the first to initiate trials in Brazil – as they have both completed the initial steps in the process of registering the immunizer with ANVISA. However, this fundamental approval will take place in phases, not immediately. Authorization for the population to be vaccinated will only occur when laboratories can prove both the safety and efficacy of their products, which will only be possible after completion of the final advanced stage.
Johnson & Johnson’s reaction
In a note, Johnson & Johnson said: “adverse events – diseases, accidents etc – even serious ones, are an expected occurrence in any clinical trial, particularly in large-scale studies. (…) We can therefore make a careful review of all medical data before deciding if the trial should be restarted.” The company has not specified what effect the subject suffered or his or her identity, for the safeguard of privacy.
Source: Veja