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The Phase 3 trial started on August 31 and enrolled about 30,000 participants at 80 locations. Now it is unclear how long the clinical hold will last. But it is obvious that other pharma companies will have to review their safety measures as well.
The UK-based pharma giant AstraZeneca Plc (LON: AZN) that has been a frontrunner in the COVID-19 vaccine race has put Phase 3 of the vaccine trial on hold. Its AZD1222 vaccine candidate, developed in collaboration with Oxford University, has shown a serious side effect in one of the patients. As a result, AstraZeneca has halted the trial and will now investigate the unexplained illness.
AstraZeneca representative commented:
“As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow the review of safety data by an independent committee. This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.”
He further added:
“In large trials illnesses will happen by chance but must be independently reviewed to check this carefully. We are working to expedite the review of the single event to minimise any potential impact on the trial timeline”.
AstraZeneca has already conducted two phases of its COVID-19 vaccine trial. Its AZD1222 drug showed promising results, and the company was one of the leading players in the vaccine race. The Phase 3 trial started on August 31 and enrolled about 30,000 participants at 80 locations. Now it is unclear how long the clinical hold will last. But it is obvious that other pharma companies will have to review their safety measures as well.
On Tuesday, AstraZeneca joined eight other biotech companies in a pledge to stick to safety and science. Besides, it promised to not seek premature government approval for any coronavirus vaccine.
At the heart of our core values is to “follow the science” and we are committed to adhere to the highest scientific and clinical standards as we research a potential #COVID19 vaccine. @Sanofi will you join us as #WeStandWithScience? https://t.co/uEaOpNBba8 pic.twitter.com/WgJestzs3D
— AstraZeneca (@AstraZeneca) September 8, 2020
Lately, the U.S. President Donald Trump has been repeatedly saying that the COVID-19 vaccine should be ready before the Election Day on November 3. This led to fears that the pre-election politics could drive vaccine decisions. To allay the concerns, executives of nine manufacturers promised to only submit potential COVID-19 vaccines for approval or emergency use authorization after demonstrating safety and efficacy. The final decision will follow a Phase III trial that meets Food and Drug Administration requirements.
Companies that joined the pledge included AstraZeneca, BioNTech SE (NASDAQ: BNTX), GlaxoSmithKline Plc (NYSE: GSK), Johnson & Johnson (NYSE: JNJ), Merck & Co Inc (NYSE: MRK), Moderna Inc (NASDAQ: MRNA), Novavax Inc (NASDAQ: NVAX), Pfizer Inc (NYSE: PFE), and Sanofi SA (NASDAQ: SNY). Six of them have already begun Phase 3 trial.
Following the news about the COVID-19 vaccine trial pause, AstraZeneca stock dropped. On September 8, it closed at $54.71, or 2.11%. However, it declined by 2.18% in the pre-market today, trading at $53.51 per share at the moment of writing. AZN market cap is $141.607 billion. Year-to-date, AstraZeneca stock is 9.73% up.