Public health authorities on Monday expressed hope that the Federal Drug Administration's approval of the Pfizer-BioNTech Covid-19 vaccine will reduce hesitancy and motivate the vaccine holdouts to roll up their sleeves.
“This is a huge milestone in our fight against Covid-19 and could not have come at a better time. FDA approval boosts confidence in the vaccine,” Public Health Director Art San Agustin said.
Although Guam has vaccinated more than 80 percent of the island's adult population, San Agustin noted that highly contagious variant strains of Covid-19 pose new threats to public health, especially among the unvaccinated.
"We are seeing a surge of cases and the hospital census continues to rise. It is imperative that more of our eligible population get vaccinated," San Agustin said.
The government has reported a total of 314 new Covid-19 positive cases, with 27 hospital admissions and another coronavirus-related death in the last two days.
About 20 percent of Guam's vaccine-eligible population has yet to be inoculated. While some critics say they are not "anti-vaccine," they are opposed to being forced to get vaccinated under duress.
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Pfizer vaccine receives full FDA approval After months of review, the FDA approved the first Covid-19 vaccine Monday. The Pfizer-BioNTech Covid-19 vaccine, an mRNA vaccine that will now be marketed as Comirnaty, has been given the nod of approval for the prevention of Covid-19 in individuals ages 16 and older. Emergency use authorization continues to be available for individuals ages 12 to 15. The Pfizer-BioNTech COVID-19 vaccine has been available under EUA since Dec. 11, 2020 for individuals 16 and older. In Guam, it became available on Dec. 17. This vaccine was then expanded to adolescents 12 to 15 years of age on May 10. “DPHSS has been advocating for vaccination not only because we believe in the safety and efficacy of these vaccines, but also because we know how much it can reduce the number of hospitalizations," San Agustin said.
Dr. Felix Cabrera, DPHSS chief medical officer, said the Covid-19 vaccines are the most heavily scrutinized vaccines in the world, having followed every strict scientific step necessary to create it.
"While we understand the initial concerns with a new vaccine, more than 4.95 billion shots have been given worldwide, with very few short-term side effects," Cabrera said.
"Meanwhile, the risk of death or serious complications from COVID-19 is significantly higher. Science has shown that the benefits of the vaccine outweigh the risk of subjecting your unvaccinated body to Covid-19,” he added.
FDA-approved vaccines undergo a standard process for reviewing the quality, safety and effectiveness of medical products. The FDA evaluates data and information included in the manufacturer’s submission of a biologics license application.
According to the FDA, to support its approval decision, it reviewed updated data from a randomized, controlled, blinded clinical trial of thousands of individuals, which supported the EUA first issued in December.
Health officials said the updated data included longer duration of follow-up in a larger clinical trial population. Based on results from the clinical trial, the vaccine was 91 percent effective in preventing Covid-19.
“The evidence is clear; the science is clear. Vaccines are our number one protection against Covid=-19 and other public health interventions. More unvaccinated people are ending up in the hospital,"DPHSS Chief Public Health Officer Chima Mbakwem said.
"More children who are not eligible are testing positive. If these reasons weren’t enough, we hope FDA approval will motivate you to get the shot."