SIOUX FALLS, S.D. (KELO) — Since the start of the COVID-19 pandemic, the world has seen remarkable strides made in the swift development of safe and effective vaccines to protect against the illness. At the time of writing one of these vaccines, the Pfizer-BioNTech vaccine, has been granted FDA approval for those age 16 and older.
However, questions and concerns still swirl around the vaccine, including what it contains, who made it and the outcomes that can result from its use. KELOLAND News gathered the facts to lay out the answers to these questions.
Who makes the Pfizer-BioNTech vaccine?
The Pfizer-BioNTech vaccine is manufactured by Pfizer, Inc., and BioNTech.
Pfizer is a multinational pharmaceutical and biotechnology company that produces products such as Xanax, Robitussin, Advil and Viagra.
BioNTech is a German biotech and immunotherapy company that had pioneered tech using messenger RNA (more on this later) joined with Pfizer in 2018 to jointly develop an mRNA-based flu vaccine prior to the onset of the COVID-19 pandemic.
According to their website, BioNTech’s collaboration with Pfizer allowed them to utilize Pfizer’s broad expertise in vaccine research and development, regulatory capabilities, and global manufacturing and distribution network while BioNTech and its partners provided a clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe.
Some confusion has been caused by the appearance of the vaccine marketed as COMIRNATY, which has led some to claim that the Pfizer-BioNTech vaccine has not been granted FDA approval. This is false. The vaccine received FDA approval on August 23, 2021, for individuals 16 years of age and older.
The confusion appears to stem from the fact that once FDA approval has been granted, companies are then allowed to market the vaccines under brand names. COMIRNATY is the brand name for the Pfizer-BioNTech COVID-19 Vaccine.
Due to the fact that the vaccine has only received full authorization for those aged 16 and up, the name Pfizer-BioNTech will still be used for those in the 12-15 year age range. While the names are different, the makeup of the vaccines is identical, and no change has been made.
The name Pfizer-BioNTech will be used for the remainder of this article.
What is the Pfizer-BioNTech vaccine?
The Pfizer-BioNTech vaccine is an mRNA vaccine. What this means is that as opposed to many other vaccines which insert a weakened or inactive germ/virus into our bodies, mRNA COVID-19 vaccines contain no actual sample of the COVID-19 virus.
Instead, mRNA in the vaccine functions as an instructional guide for bodies’ cells to create a harmless piece of the spike protein that the COVID-19 virus uses to enter our cells. According to the CDC, once the cells produce the spike protein, the messenger RNA is no longer needed and is broken down by the cell. It is important to note that while RNA (ribonucleic acid) is similar to DNA (deoxyribonucleic acid), mRNA does not enter the nucleus of our cells where our DNA is stored. This means that the mRNA does not affect and cannot change our genetic material.
Following the creation of this dummy spike protein, the cell displays the spike on its surface, allowing it to be noticed by our immune system, which then begins building an immune response and producing antibodies, just as it would in the event of an exposure to the actual COVID-19 virus, but without the risk of actually catching the virus.
While mRNA vaccines are a new technology, the research on it goes back decades. According to Johns Hopkins University, mRNA was discovered in the 1960s and research into its application to human cells was developed in the 1970s.
One of the biggest barriers to the application of mRNA in the early years of study was the speed with which it is broken down by the human body, leading to its destruction before it ever had the chance to deliver to the cells the info which it was carrying.
The solution to this problem came from advances in nanotechnology: the development of fatty droplets (lipid nanoparticles) that wrapped the mRNA like a bubble, which allowed entry into the cells.Johns Hopkins University
Johns Hopkins states that the first use of mRNA vaccines using this method of delivery was developed to counter the Ebola virus, but due since the virus was only found in a handful of African countries, the vaccine had no commercial development in the U.S., where only four patients were ever diagnosed with the illness.
The CDC notes that mRNA vaccines have also been studied for flu, Zika, rabies, and cytomegalovirus. They also report that cancer research has used mRNA to trigger the immune system to target specific cancer cells.
What ingredients are in the vaccine?
- Nucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2
Lipids: Lipids are fatty, waxy or oily compounds that are able to be dissolved in organic solvents such as those found in the body. According to the Connecticut Department of Public Health (CDPH), lipids protect the mRNA and provide a “greasy” exterior that helps the mRNA slide inside cells.
- 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide
Salts, sugars and buffers: The CDPH explains that salts, sugars and other buffers are used in the vaccine to help balance acidity in the body and to assist the molecules in keeping their shape while frozen for storage and transportation. Sodium chloride is basic table salt, while Sucrose is just sugar.
- Potassium chloride
- Monobasic potassium phosphate
- Sodium chloride
- Dibasic sodium phosphate dihydrate
You can view a full list of the ingredients in all three vaccines authorized for use in the U.S. here.
The Pfizer-BioNTech vaccine does not contain eggs, preservatives, latex or metals of any kind.
How effective is the vaccine?
According to the CDC, based on evidence from clinical trials in people 16 years and older, the Pfizer-BioNTech vaccine was 95% effective at preventing laboratory-confirmed infection with the virus that causes COVID-19 in people who received two doses and had no evidence of being previously infected.
The vaccine has also been highly effective in the prevention of COVID-19 infection in adolescents 12–15 years old, and the immune response in people 12–15 years old was at least as strong as the immune response in people 16–25 years old.
What are the known side effects?
Possible side effects of the vaccine include pain, redness and swelling at the site of the injection. Tiredness, headaches, muscle pain, chills, fever and nausea have all been reported as well. These side effects are not signs of illness caused by the vaccine, but rather the effect of our bodies’ immune systems reacting to the spike protein and working to build an immune response.
Side effects generally can be expected within the first two days after vaccination, and generally, go away within a few days.
Adverse effects to the vaccine
Serious adverse effects to the Pfizer-BioNTech vaccine are rare, but possible. The CDC gathers reports of adverse events through its Vaccine Adverse Event Reporting System (VAERS).
Anaphylaxis: Anaphylaxis is a severe allergic reaction leading to skin rash, nausea, vomiting, difficulty breathing, and shock. It can be fatal. Anaphylaxis following COVID-19 vaccination is rare, and according to CDC data has occurred in around 2-5 people per million vaccinated in the U.S. Severe allergic reactions of this sort can occur after any vaccination.
Thrombosis with thrombocytopenia syndrome (TTS): TTS is a rare syndrome in which the formation of blood clots combines with low blood platelet levels which can lead to long-term disability or death if not treated. The CDC and FDA have identified 47 confirmed reports of TTS in those who have received a dose of the J&J/Janssen COVID-19 vaccine, which has been administered to nearly 15 million Americans.
To date, there have been two reported cases of TTS in people who have received the Moderna vaccine, which has been administered to more than 376 million people in the U.S. So far, there do not appear to be any reports of TTS in those who have received the Pfizer-BioNTech vaccine in the U.S.
Myocarditis and pericarditis: Myocarditis is inflammation of the heart muscle, and pericarditis is inflammation of the outer lining of the heart. These conditions are rare following COVID-19 vaccination. As of Sept. 29, VAERS had received 1,590 reports of myocarditis or pericarditis among people ages 30 and younger who received the COVID-19 vaccine.
Most cases have been reported after mRNA COVID-19 vaccination (Pfizer-BioNTech or Moderna), particularly in male adolescents and young adults. Through follow-up, including medical record reviews, CDC and FDA have confirmed 906 reports of myocarditis or pericarditis.CDC
It is not yet known whether there is a relationship between these instances of myocarditis and pericarditis and the COVID-19 vaccines, but the CDC says the matter is being investigated.
Death: More than 396 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through October 4, 2021, according to the CDC.
Through this time, VAERS received 8,390 reports of death (0.0021%) among people who had received a COVID-19 vaccine. It is extremely important to understand that these are reports of people who died and were also vaccinated, and not people who died because they were vaccinated.
The Vaccine Adverse Event Reporting System is an early warning system used to monitor adverse events that happen after vaccination. The purpose of the system is to allow vaccine safety experts to study any and all potential adverse effects of a vaccine. Due to this, when a health problem is reported to VAERS, it does not necessarily mean that the vaccine caused the problem.
The FDA requires healthcare providers to report any death after COVID-19 vaccination to VAERS, even if it’s unclear whether the vaccine was the cause. Due to this, a person killed in a car crash who also happened to be vaccinated would be included in this statistic.
The CDC states that a review of available clinical information, including death certificates, autopsy, and medical records, has not established a causal link to COVID-19 vaccines.
It should also be noted that VAERS is not a closed system. Anyone can submit a report to VAERS, including patients, parents or caregivers, healthcare providers, and vaccine manufacturers.
Vaccine safety experts review all reports of serious adverse events submitted to VAERS, which include permanent disability, hospitalization or an extended hospital stay (if vaccinated while in the hospital), life-threatening illness, birth defects (congenital anomalies) and death.
When VAERS staff members follow-up on a report of a serious adverse event, they ask for the patient’s medical records related to the event to learn more about what happened.
The CDC emphasizes that VAERS reports alone generally cannot be used to determine if a vaccine caused or contributed to an adverse event or illness.
Some reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. VAERS reports often lack contextual information, such as total vaccinations given or information on unvaccinated groups for comparison. Most reports to VAERS are voluntary, which means they may be subject to biases. Data from VAERS reports should always be interpreted with these limitations in mind.CDC
Due to these factors, any claim citing VAERS data that attempts to state that the vaccine has resulted in thousands of deaths is inaccurate, misleading and unsubstantiated.
Black box warnings
Black box warnings are the strongest form of warning required by the FDA for prescription drugs, and are meant to alert patients and health care providers to increased risk of serious adverse reactions with a medication or restrictions to using the particular drug.
Courtney Feist, a Clinical Pharmacist for Lewis Drug explained to KELOLAND News via email that the Pfizer-BioNTech vaccine does not carry a black box warning. “There are warnings/precautions, but not a specific black box warning,” she said. “Like I mentioned there are warnings and precautions with the Pfizer vaccine, which can be found in the patient and provider fact sheets that are available.”