With a society living in a pandemic for over a year now, many are concerned about vaccinating to prevent further spreading of Covid-19.
Pfizer’s request to roll out COVID-19 vaccines for Americans as young as 5 years old is facing its first key regulatory test on Tuesday, as a panel of the Food and Drug Administration’s outside vaccine advisers meets to weigh the potential benefits and risks of vaccinating younger children.
We’ve all heard in the news or by word of mouth about side effects like blood clotting, autoimmune diseases, loss of pregnancy, and low fertility rate, after taking the Covid vaccinations.
So are the vaccinations really safe? This is the question that weighs heavy on many parent’s minds.
The meeting Tuesday of the FDA’s Vaccines and Related Biological Products Advisory Committee is a crucial step towards vaccinations for younger children, but not the final word. Federal health officials hope first doses could begin as early as the first week of November, pending sign-off from the FDA and the Centers for Disease Control and Prevention.
“It is critically important from both a health and trust standpoint that we allow this process to play out rather than simply assuming the vaccine will be authorized,” Dr. Richard Besser, former acting CDC director and president of the Robert Wood Johnson Foundation said.
While the panel’s vote will not be binding, a positive result could clear the way for shots to soon be authorized by the FDA. If the agency decides to allow the vaccine, the Biden administration says up to 15 million child-sized doses of Pfizer’s vaccine could be shipped out to providers immediately after the FDA’s decision.
Under federal supply agreements, vaccinators will still need to wait for the Centers for Disease Control and Prevention to formally recommend use of the shots before they can be put into arms. The CDC’s own panel of vaccine advisers are scheduled to meet on November 2 and 3 to debate pediatric vaccinations.
“The data that have been released to date are promising, but independent scientific review must guide this process,” said Besser.
Results from Pfizer’s clinical trials, released ahead of the FDA’s meeting, suggest that the vaccine was more than 90% effective at protecting against symptomatic COVID-19 when given in two smaller doses formulated for younger children.
Safety data from more than 3,000 children who received the vaccine in Pfizer’s trials turned up no “new safety concerns.” The smaller dose’s side effects were similar, or in some cases less frequent, than those seen in adolescents and young adults. Pfizer’s vaccine is currently authorized for ages 12 and up.
Much of the committee’s discussions on Tuesday are expected to center on whether the potential risks of rare side effects linked to the shots — types of heart inflammation called myocarditis and pericarditis — are outweighed by the vaccine’s potential benefits for a population that is far less likely to face a severe case of COVID-19.
Though the reported cases of myocarditis and pericarditis in adolescents and adults have often been mild and resolved within a day, most typically require hospitalization.
With death numbers currently down and children being at the least amount of risk from contracting and dying from Covid-19, is it really worth the risk of vaccinating your child?
Although the FDA and Biden Administration seem to find the side effects a light risk, heart problems are nothing to overlook.
During recent studies of the COVID-19 vaccines administered in the U.S., CDC officials said earlier this month that they had confirmed 877 reports of myocarditis or pericarditis potentially linked to the shots in Americans younger than 30 years old.
This can be very crucial to someone that already has a pre-exsisting heart condition.
With numbers being down and recent Covid symptoms being compared to a more severe flu, is it worth taking the risk to vaccinate? This is a conundrum that parents will face very soon.
