By the end of the year, the first innovative COVID-19 vaccines will be accessible, and although this is good news to government health officials, polls have also shown that the confidence of people in the Covid-19 vaccination appears unstable.
Director of the National Institute of Allergy and Infectious Diseases, Dr. Anthony Fauci, sought to address suspicions regarding the efficacy of the first two vaccines where the early Phase 3 clinical study outcomes have been documented in a White House Task Force conference on Thursday.
Dr. Fauci had this to say: "The process of the speed did not compromise at all safety nor did it compromise scientific integrity." He also added that: "It was a reflection of the extraordinary scientific advances in these types of vaccines which allow us to do things in months that took us years before."
COVID-19 vaccine effectiveness
On Wednesday, marking the conclusion of Phase 3 clinical study, Pfizer and its German affiliate, BioNTech, published further results. The manufacturers confirmed that their vaccines had been 95% effective in controlling the Covid-19 disease, development over the 90% effectiveness recorded a week earlier by Pfizer in the previous trials.
Moreover, analysts agree these outcomes are promising, but understanding what these could mean, more information is needed.
"Ninety-five percent effective is amazing, but the question is: effective at what?" Director of the Institute for Vaccine Safety in the Johns Hopkins Bloomberg School of Public Health, Daniel Salmon, stated. "Does it prevent contracting the disease altogether? Does it prevent clinical disease? Does it prevent serious disease? And does it prevent transmissibility? Those are different questions," he added.
Early findings of its Phase 3 study indicates that the manufacturer's groundbreaking vaccine is 94.5 percent effective at minimizing infection, Moderna reported on Monday.
COVID-19 side effects
As one of the emergency use request, the FDA needs the vaccine manufacturers to provide two months of follow-up trial data. Such is a crucial element in ensuring that drug companies are able to track subjects in the study for any significant safety risks after vaccination.
Commonly, according to Dr. Grace Lee, a professor of pediatrics at Stanford University School of Medicine, several side effects from vaccines occur within 60 days of getting the injection. However, unusual problems may occur later, suggesting that the FDA may need to balance the possible benefits over the potential risks before approving authorization for emergency uses.
If a coronavirus vaccine is approved for emergency use, the Advisory Committee would eventually provide guidelines as to who should get the vaccinations first.
A member of the Advisory Committee on Immunization Practices for the Centers for Disease Control and Prevention, Lee had this to say: "We're going to have to accept that there are going to be risks - nothing we do in this world is risk-free."
Vaccines reviewed by independent scientists
A process is in motion to review statistics on vaccines before permission is given and deemed accessible to the public. An independent panel of FDA experts such as the Vaccines and Related Biological Products Advisory Committee will evaluate a request for an emergency use permission.
Moreover, the FDA will determine whether it should issue permission for emergency use after the panel provides its guidelines. The Advisory Committee on Immunization Practices would then develop guidelines for the CDC on how to allocate who receives the shot first.
