BRITISH INFORMATIONAL ON PFIZER VACCINE DAMPERS MANDATORY VACCINATION EFFORTS
Julio Gonzalez, M.D., J.D.
A few weeks ahead of when the FDA is expected to grant its Emergency Use Authorization for the Pfizer COVID-19 vaccination, the United Kingdom granted the company its green light for proceeding with the distribution of its much-anticipated vaccine. Formally known as "COVID-19 mRNA Vaccine BNT162b2 concentrate for solution for injection" the UK recently released its informational packet for healthcare providers. The document offers significant insights regarding the vaccine and safety considerations related to its use. It also casts sufficient doubts regarding our present understanding of the vaccine's risks and benefits to sour any attempt at enacting mandatory vaccination policies. Below is a summary of the data shared in the informational:
The solution is a "white to off white frozen solution" available in vials of 0.45 ccs meant for dilution into 5 doses in its final form. The vaccine is to be administered in a series of two, intramuscular injections of 0.3 ccs each, twenty-one days apart. Patients may not be protected for at least 7 days following the administration of the vaccine's second dose, meaning that recipients ought not expect to be protected for about 30 days after they receive their first dose assuming they receive their second dose 21 days later.
A vial may be kept at -80 to -60 degrees Celsius for 6 months. A frozen vial may be thawed at room temperature over 30 minutes. Once at room temperature, that vial may be stored for up to 2 hours prior to use, or at 2 to 8 degrees Celsius for up to five days. Once the vaccine is diluted to its usable form, it must be used within 6 hours and may not be refrozen.
The safety of the vaccine has not been determined for patients under 16 years of age, thus it is not recommended for use in children 15 years of age or younger. Additionally, there is no definitive information regarding the use of the vaccine in pregnancy, making it not recommended for use in expecting mothers. In fact, the company is recommending that pregnancy be ruled out in women of childbearing age and that they avoid getting pregnant for at least two months following the vaccine's administration. Additionally, because it is not known whether the vaccine is secreted in lactated milk, it should not be administered to women who are lactating. More broadly, it is not known what effects the vaccine may have on fertility; men's or women. Thus, for now, individuals who are interested in childbearing should take caution.
According to the Information Sheet, "[t]he most frequent adverse reactions in participants 16 years of age and older were pain at the injection site (> 80%), fatigue (> 60%), headache (> 50%), myalgia (> 30%), chills (> 30%), arthralgia (> 20%) and pyrexia (> 10%) and were usually mild or moderate in intensity and resolved within a few days after vaccination."
Evidence of efficacy was largely based on a study where the vaccines were administered to over 44,000 subjects. In those who were 65 years of age or older, there was a 94.6% efficacy of COVID-19 infection prevention. On those who were 75 years of age or older, the efficacy was 100%. The efficacy in preventing COVID-19 was statistically significantly improved in the group receiving the vaccine over the group receiving a placebo.
To this point, precious little is known regarding the performance of any of the vaccines being prepared for administration in the United States. The British informational is amongst the first, government-reviewed sources of recommendations and precautions regarding any of these products. As such, it provides the general public with valuable insights regarding the Pfizer vaccine specifically. In short, the efficacy of the vaccine in preventing disease is impressive. A 94.7% efficacy rate is certainly hard to beat. It is in the risks where the uncertainty lies. Despite the optimism, there is much that remains unknown regarding the effects of the vaccine on pregnant and lactating women. Importantly, the unanswered questions regarding future fertility are problematic for individuals still in their childbearing age. Although these concerns may not be sufficient to block the generalized distribution of the vaccine, it does hamper potential mandatory vaccination efforts. Neither government, nor employers, nor service organizations can safely require a vaccinated status as a precondition to hiring, traveling, gathering, or other social activities in light of these uncertainties. Requiring people to vaccinate as a precondition when nothing is known about the effects of the vaccine on issues as essential as fertility is beyond the pale, not to mention the myriad of questions left unanswered such as immune responses, potential increased susceptibility to other conditions, and length of immunity.
We should all keep these questions in mind as developments regarding efforts aimed at mass vaccinations materialize.
Dr. Julio Gonzalez is an orthopaedic surgeon and lawyer living in Venice, Florida. He served in the Florida House of Representatives. He is the author of numerous books including The Federalist Pages, The Case for Free Market Healthcare, and Coronalessons. He is available for appearances and book signings, and can be reached through www.thefederalistpages.com.
Dr. Julio Gonzalez is an orthopedic surgeon living in Florida. He is a lawyer, author, and former member of the Florida House of Representatives. He is available for speaking engagements at email@example.com