FDA Approves Pfizer COVID-19 Vaccine

With 17 approval, 4 against, and 1 abstaining, the FDA has now approved authorization for emergency use of the Pfizer COVID-19 vaccine. A briefing document was released by the FDA which outlined clinical trial data on safety and efficiency of the vaccine. This document confirms that the vaccine protects against symptomatic infection of SARS-Cov-2 with 95% efficiency after 7 days from the second dose.

Dr. Reynold Panettieri Jr. stated that the vaccine trials had “very impressive data that exceeded most expectations” and also pointed out the high efficiency in the elderly with an average age over 55 at 93.7% — the younger age groups had a 95.6% efficiency rate; however, it is important to remember that real life efficiencies are often lower and large clinical trials often times have serious illnesses arise during, which may or may not be caused by the vaccine.

Efficiency is high across most subgroups except for those identifying as multiracial and those who had infection prior to the study due to too few participants in these data groups. The data comes from 38,000 participants ages 16 and older during phase 3 in a randomized trial where one group received the vaccine in 2 doses across 3 weeks or 2 doses of an inactive placebo during the same time period.

Benefits were seen after a little over a week from the first dose with a plateau of cases around 10 days after in the control group while the placebo group continued to rise. A single dose may not be sufficient, with efficiency between both does 52.4% lower than with the second dose. Most participants received the second dose 21 days after the follow up period and thus the results cannot show support on a single dose. Trials suggest that there is protection from severe COVID-19 infection, however the small number of cases during the trial cannot confirm.

The FDA did not raise any significant concerns for vaccine safety, with the most common side effects being pain at the injection site, fatigue, headache, muscle pain, chills, joint pain and fever. Most side effects were mild to moderate, lasting for about a day and a small number had severe reactions.

Of the participants who had a serious adverse reaction there were 4 occurrences of Bell’s Palsy — a condition that causes temporary paralysis or weakness of facial muscles — and none in the placebo group. The frequency of this occurrence is not above what is seen in the general population, but this reaction will be monitored. Another adverse reaction seen was lymphadenopathy (swollen lymph nodes), 64 cases occurred in the vaccinated group and 6 in the placebo group.

Those with prior allergic reactions to medicine or foods should heed with caution due to risks.

Groups with not enough data include those ages 16 and younger, those who are pregnant or breastfeeding, and those who are immunocompromised — including HIV — which still do not have enough data to back efficiency.

Hospitals should stagger vaccine distribution among employees to avoid too many experiencing side effects at the same time or have them vaccinate prior to off days so they can recover at home. Other concerns surrounding the vaccine include how long protection lasts, if it protects those who are asymptomatic, and if receiving the vaccine stops one from still passing the virus; these concerns need more studies so continued preventative measures are encouraged.

The US has ordered 100 million vaccines which will be able to vaccinate 50 million people. Concerns still arise around the distribution and storage of the vaccine due to the very low storage temperature of -96° and the logistics of vaccine usage during the vaccination process.

About Us

Here at HealthNeed Medical Urgent Care, our main goal is to provide an easy and friendly walk-in experience that will have you face to face with one of our many medical specialists within minutes of checking in and without an appointment. Our team of medical experts offers treatments anywhere from bandaging small scrapes and cuts to IVs. Come check out our offices that are open 365 days a year. We provide pediatric as well as senior medical care, with most health insurances accepted.

Queens Crossing
38–21 Main St, Suite 1A
Flushing, NY 11354

Wheelchair Accessible Entrance:
136–17 39th Ave, Suite 1A
Flushing, NY 11354

Phone: (718) 888–1808

Terms of Use and Disclaimer — The information contained in this document has been culled from online resources and government agencies and is for general informational purposes only. The information is provided in good faith to support the community and our friends impacted by the COVID-19 pandemic. We makes no representation or warranty of any kind, express or implied, regarding the accuracy or completeness of the information contained herein. Your use of this document and your reliance on the information contained herein is solely at your own risk. All liability with respect to any reader, user or browser’s reliance on this document and/or actions taken or not taken based on the contents of this document is hereby expressly disclaimed.