In the week of November 2nd, AstraZeneca delivered some disappointing news to UK lawmakers: the COVID-19 vaccine, developed in collaboration with the University of Oxford, would not be available during the winter holidays.
Andrew Pollard, PhD, director of vaccine trials at Oxford University and AstraZeneca, told members of the Science and Technology Committee and the Health and Social Welfare Committee that a vaccine may not be ready until after Christmas. Dr. Pollard said that while a vaccine could be completed before the end of the year, it would not be the same as deployment. Before this can happen, regulators must review and approve the work of the team. “We have to do this so that everything that has been done in the clinical trials is checked very carefully,” said Dr. Pollard. After that, Dr. Pollard, the final step is for policy makers to decide how the vaccine will be allocated.
Dr. Pollard said there are many steps before deployment can go ahead. Previously, the supervisory authorities had to assess and approve the work of the team. “We absolutely need this so that everything that has been done in the clinical studies is checked very carefully.” After that, Dr. Pollard, the final step is for policy makers to decide how the vaccine will be allocated.
Dr. Pollard mentioned that other vaccine candidates may be approved and available before the Oxford / AstraZeneca vaccine. “To have [a] Delivering vaccines to 7 billion people may really take a lot of success from all developers, “he said.
While the FDA has set a goal of 50% effectiveness, Dr. Pollard that a less effective vaccine, say 40%, might still be useful. He stated that the decision will be made by the policy makers. About the possible vaccines, Dr. Pollard: “We have to think about how we would deal with less effective vaccines.”
The FDA has made the use of vaccines easier, as there is no pre-inspection of the production facilities or the public comment period. A preliminary check shows that the plant can safely produce its product and that the FDA says the on-site manufacturing is in accordance with the plans submitted by the company. Although the FDA’s move has been criticized, let alone the global lack of trust in political leadership, the FDA has not required a pre-approval inspection even under normal circumstances, according to Jerry Weir, PhD. Dr. Weir is the director of the viral products division at the FDA. He spoke about the vaccine in a meeting last week. One participant countered: “It would create additional trust in the process.”
“People can forgive the failure of a vaccine because of the great difficulty of preventing Covid-19 infection,” wrote William Haseltine, Ph.D. in Forbes. “They are not going to give a vaccine that puts their lives at risk due to manufacturing defects,” he said. Haseltine is a Forbes associate and a former professor at Harvard Medical School and its School of Public Health.
One reason cited from AZ – and even Pfizer in its belated vaccine results – is ironic, to say the least, and symbolic of the off-chart events of 2020.
The reason given by AZ and Pfizer, who also had to revise the vaccine approval schedule, is that the pandemic slowed over the summer. There weren’t enough infected people in their large phase 3 studies. Without the required number to test the vaccine’s effectiveness against a placebo, the researchers had to wait. In a recently published guide by the FDA, an emergency use application will only be approved if there is at least two months of safety data available for review after the final vaccine dose has been delivered.
Sabrina Emms is a science journalist who has worked as a researcher studying the way bones are formed.
With additional reporting by Christine Bahls