Source : 'The Pink Sheet'
Sponsors interested in developing vaccines for COVID-19 should accelerate the process by using their existing vaccine manufacturing platforms, according to Peter Marks, director of the US Food and Drug Administration’s Center for Biologics Evaluation and Research.
The CBER director echoed recent regulatory guidance in emphasizing this point in his remarks at a 14 September joint regulatory conference sponsored by the FDA and the Parenteral Drug Association, conducted virtually this year due to the pandemic.
Marks also urged manufacturers to be prepared to conduct extensive post-market surveillance studies for their COVID-19 vaccines. He also said that manufacturers should plan to enroll a more diverse group of patients in later-stage studies.
Marks stressed the importance of having high-quality COVID-19 vaccines, especially since safety and efficacy data for these products will be limited. He said that the safety and efficacy of these vaccines "stem from quality, and you can't re-engineer quality into a vaccine." This means that "we have to think about the consistency of manufacturing and appropriate scale-up."
He said that the agency’s recent guidance on developing COVID-19 vaccines addresses some of the chemistry, manufacturing and controls information needed for these applications. ("COVID19 Vaccine Should Demonstrate At Least 50 Effectiveness US FDA Says" "Pink Sheet" ) The guidance encouraged COVID-19 vaccine sponsors in June to use the same manufacturing platform as for their other vaccines, just as Marks recommended at the PDA/FDA conference.
The guidance says that “COVID-19 vaccine development may be accelerated based on knowledge gained from similar products manufactured with the same well-characterized platform technology, to the extent legally and scientifically permissible. Similarly, with appropriate justification, some aspects of manufacture and control may be based on the vaccine platform, and in some instances, reduce the need for product specific data.”
Marks said that “a number of manufacturers are taking the type of approach and using a tried and tested vector” that they have used before.
He added that sponsors are using eight different technologies or platforms in developing COVID-19 vaccines, including DNA, RNA, inactivated viruses and non-replicating viral vectors.
Marks encouraged manufacturers to cast a wider net and enroll a more diverse patient population in later-stage studies. This includes enrolling more minorities, women of child-bearing age, children and the elderly to more thoroughly assess the effect of the vaccine on patients.
“We are encouraging those who are developing vaccines to enroll all patients, particularly racial and ethnic minorities -- the people who should reflect the people given the vaccine at the end of the day.”
The lack of initial clinical trial data for COVID-19 vaccines in children will make focusing on adult vaccine confidence and uptake even more critical, US Surgeon General Jerome Adams told Congress on 9 September. ("COVID19 Vaccination Gaps In Pediatric Data Make Adult Uptake More Vital Surgeon General Says" "Pink Sheet" )
Marks also sought to reassure the audience that there is a transparent process in place for reviewing and approving vaccines.
He said that “many people are concerned that in the rush to develop a vaccine, steps will be missed, or a potentially unsafe vaccine could be produced. One way that we have tried to maintain vaccine confidence in the past is by making sure that we have a very transparent process. The importance of vaccine confidence cannot be underestimated, and we know that from the measles outbreak where people did not get vaccinated against measles. We once again see susceptibility to this infection. It’s a shame because measles, which is associated with a certain number of deaths, can be prevented by a vaccine that has very few side effects.”
By Joanne S. Eglovitch