Nine Biopharma Companies Sign Pledge To Safely Develop & Deploy A COVID-19 Vaccine Medicines & Vaccines 09/09/2020 • Grace Ren Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Electron microscope image of SARS-CoV-2, the virus that causes COVID-19 The chief executive officers of nine biopharmaceutical companies at the forefront of the COVID-19 vaccine development race have signed a pledge to fully test the safety and efficacy of an investigational vaccine before rolling it out for mass use. The top executives of AstraZeneca, BioNTech, GlaxoKlineSmith, Johnson&Johnson, Merck, Moderna, Novavax, Sanofi, and Pfizer signed the safety pledge on Tuesday, following reports that the CEOs were preparing such a safety pledge on Saturday. News of the safety pledge coincided with reports Tuesday evening that AstraZeneca, which is one of the leading pharma companies in the race to develop a COVID-19 vaccine, was suspending it’s Phase III trials underway in four countries in collaboration with Oxford University, to investigate a report of a possible severe adverse reaction in one UK participant. The AstraZeneca move was made out of “an abundance of caution,” a person familiar with the trials told STAT News – noting that such pauses are not uncommon. The trial may be resumed once the cause of the reported reaction is investigated, and if the vaccine is still deemed to be safe. However, it’s unclear how long the suspension will last. “We voluntarily paused vaccination to allow 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,” an AstraZeneca spokesperson said in a statement to STAT News. Amidst pressure from the Trump administration to begin wider roll-out of a vaccine before the US presidential election in November, pharma companies have taken the initiative to reassure the public that any potential COVID-19 vaccine will be properly tested before it receives regulatory approval. “We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles,” the companies wrote in the pledge. Pharma Pledge Comes Amidst Pressure to Speed Up Approval The pledge comes as countries’ regulatory authorities have faced pressure to release an investigational vaccine for wider use, even as large final phase clinical trials are still ongoing. Phase 3 clinical trials for the coronavirus vaccine candidates, which closely monitor the safety and efficacy of an investigational product in thousands of people, will not be complete before the end of the year. However, the United States CDC notified US state officials in late August that a vaccine could be available for wider use by late October, just in time for the US presidential election on November 3rd, according to the New York Times. And Russia approved a vaccine, aptly named “Sputnik 5,” before Phase 3 trials had concluded in mid-August. The move has drawn criticism and offers to collaborate by governments seeking new ways to combat the pandemic. China in July approved a SinoVac’s vaccine candidate for emergency use, and media reports have found that nearly all of SinoVac’s employees and many of the employees’ family members have received the experimental vaccine. The Gamaleya Institute, the developer of Russia’s approved vaccine, and SinoVac are not among the companies who have signed the pledge. However, Phase 3 trials for both companies’ vaccine candidates are currently underway. The rapid approval of COVID-19 vaccines has drawn criticism from a number of researchers and public health specialists, who have warned governments against prioritizing speed over safety in releasing a vaccine. The World Health Organization has also recommended that countries wait for results from Phase 3 clinical trials before attempting to roll out a COVID-19 vaccine en masse. Companies Pledge To Seek Regulatory Approval Only After Phase 3 Studies Show Safety And Efficacy Key to the nine companies’ pledges is the promise to seek any regulatory approval, even emergency use approval, only after the vaccine demonstrates safety and efficacy in large scale, final phase clinical trials. The trials used to test the vaccine must also be designed to the highest clinical research standards, and ensure the vaccine is safe and effective in a large and diverse group of people. “Following guidance from expert regulatory authorities such as FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to..only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA,” the companies wrote in the pledge. Additionally, the companies made three further promises: Always make the safety and well-being of vaccinated individuals their top priority. Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes. Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access. Together, these nine companies represent some of the biggest vaccine developers in the world, and some of the most promising biotech firms. All companies are invested in investigational COVID-19 vaccines that are currently in Phase 3 trials. Image Credits: National Institute of Allergy and Infectious Diseases, NIH. 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