- AstraZeneca’s COVID-19 trial is anticipated to recommence in the US as early as this week after the FDA completed its review of a serious illness, as mentioned by Reuters.
- The UK-based biopharma player’s trial was put on hold when a volunteer developed some unexplained illness.
- Regulators in Japan, Brazil, India, UK, and South Africa allowed AstraZeneca to resume its COVID-19 vaccine trials at their respective sites.
AstraZeneca’s COVID-19 clinical trials in the US are anticipated to start again as early as this week after the US Food and Drug Administration (FDA) completed its review of a serious illness, sources told Reuters. As per one of the sources, the agency requires researchers conducting the trial to add information about the incident to consent forms signed by study participants.
AstraZeneca Plc (LON:AZN) and the University of Oxford are developing a COVID-19 vaccine, with its candidate, AZD1222 currently under Phase 3 clinical trials. On 9 September 2020, AstraZeneca updated the market that the Company had suspended the late-stage clinical trial of its COVID-19 vaccine candidate after a volunteer had developed an unexplained illness.
AstraZeneca and Oxford University were counted among the frontrunners in the race to develop COVID-19 vaccine until the clinical trials were put on hold to investigate the illness. The pause in the trial in the US could have caused the biopharma giant to lag behind other vaccine developers like Pfizer Inc (NYSE:PFE), BioNTech SE (NASDAQ:BNTX) and Moderna Inc (NASDAQ:MRNA).
Lately, on 6 October 2020, the FDA issued new guidance for COVID-19 vaccine developing companies. The new guidance mentions that the vaccine developers are required to offer at least two months of follow-up for safety data after vaccine administration to trial subjects before applying for the authorization. That makes COVID-19 vaccine authorization before the US presidential election highly unlikely.
About AstraZeneca Plc
Cambridge, UK based global biopharmaceutical player AstraZeneca Plc is engaged in the discovery, development as well as commercialization of prescription drugs. Mainly, AstraZeneca offers treatment for diseases in the areas of oncology, renal & metabolism, respiratory, and cardiovascular. AstraZeneca’s innovative therapies are used by millions of patients across the world.
AstraZeneca’s Trials Resume in Japan, Brazil, India, UK, and South Africa
Regulators in Japan, Brazil, India, UK, and South Africa allowed AstraZeneca to resume its COVID-19 vaccine trials at the respective sites.
The regulatory officials of the UK had earlier reviewed an illness caused by the vaccine candidate. They concluded that there was insufficient evidence to declare that it was or was not related to the vaccine. Moreover, the regulators permitted the trial to resume enrolling participants in the UK, as stated by Reuters.
After three days of halting the study, on 12 September 2020, AstraZeneca recommenced clinical trials of AZD1222 in the UK following the confirmation by the MHRA (Medicines Health Regulatory Authority) that the vaccine was found safe to perform trials.
Pfizer Sees EUA Filing For COVID-19 Vaccine Post US Election
Another top contender in the list of vaccine developers, New York-headquartered Pfizer Inc, is developing a COVID-19 vaccine with Germany based company BioNTech. The pharma behemoth recently disclosed that the Company might file for authorization of the COVID-19 vaccine in late November.
Pfizer notified that it is unlikely that a vaccine will be available before US elections as President Donald Trump has promised. The Company stated that the regulatory filing for the COVID-19 vaccine could take place as soon as the safety data is available, likely in the 3rd week of November.
In an open letter, Pfizer Chairman and CEO, Albert Bourla said that in the instance of Emergency Use Authorization (EUA) in the US for a potential COVID-19 vaccine, the FDA is necessitating that companies provide two months of safety data on half of the trial participants after the final dose of the vaccine.
Based on the current enrollment and dosing pace, the Company anticipates it will reach this milestone during the 3rd week of November.
It seems highly unlikely that a potential COVID-19 vaccine would be launched before the US elections as promised by President Donald Trump. However, according to media sources the trials of AstraZeneca’s COVID-19 vaccine would likely resume clinical studies before elections.
Nevertheless, following the launch of FDA’s new guidance for COVID-19 vaccine developers, the idea that a vaccine candidate could be approved anytime soon seems a bit far-fetched.