Given the grim situation of coronavirus cases and related deaths in the US, the Food and Drug Administration (FDA) has advised the vaccine makers to start working on vaccine modifications to fight the coronavirus variants.
FDA advised the pharma companies to quickly work on the modified shot and release these for public use without any need for extended clinical trials.
Dr. Janet Woodcock, the acting FDA commissioner said in a statement that they are using every single tool present in their toolbox to handle the situation and fighting the pandemic, this includes pivoting with the adaptations in the coronavirus.
Vaccine Makers Should Modify Shots For New Variants: Advised FDA
The FDA guidelines that were issued on Monday are for the companies and therapeutics that are involved in making the vaccines. The guidelines also cover the companies that work on diagnostic tests. The FDA has advised the companies to keep up their work with the pace of the mutating and evolving SARS-Cov2 virus.
Though the evidence is indicating that the two messenger RNA-based vaccines, Pfizer and Moderna, are quite effective against the new variants, there is still a need to keep up the pace with the evolving virus. The Pfizer and Moderns vaccines were given emergency approval last year.
The virus is mutating quickly, with many new and deadlier variants already circulating in the community. One therefore need to keep up so that immediate steps could be taken against the virus if required.
The FDA has provided a ground to these companies to skip the lengthy clinical trial procedure to prove the safety as well as the effectiveness of the modified vaccines against the new variants.
The trial skip is unlike the flu shots produced every year. Because the scientist and producers are used to the flu virus and they readily skip the clinical trials for flu shots if modified.
According to Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, they are very much accustomed to skip the clinical trials in case of influenza virus.
He said that the flu virus is very well studied. Manufacturers are allowed to modify the flu shots based on the strains of the influenza virus that is expected to be in circulation. Clinical trials in that case are unnecessary.
But this is not the case with the SARS-Cov2 virus. According to FDA, the drug-makers are still required to test for the efficacy of the drug against the emerging strains. This will continue till a significant amount of study with enough confidence is made on the virus.
According to Mark, additional safety data about the modified vaccine is required. They need to ensure that the shot is effective against both the older virus strains as well as the newly evolved strains.
Mark said that once such modifications in vaccines are found to give consistent results then it will be easy to move to the influenza like model. At that time vaccines will directly be made available to people after modifications as per the virus strain n circulation. The hectic trials would then be skipped.
In the guidelines the FDA has also directed and recommended the developers of the coronavirus vaccine and diagnostic tests to monitor regularly the effectiveness of the product towards the emerging virus. The makers of the monoclonal antibody treatments are also asked to follow the same.
The Food and Drug Administration (FDA), is working constantly to prevent the United States from infectious diseases and health threats including the recent COVID-19 pandemic.
Therefore, FDA issues regular guidelines to support the cause. The recent guidelines are also in accord with their crucial role to protect the country from the new variants of the virus.