The Pfizer COVID Vaccine is here. And I have a lot of my patients in the pulmonary clinic asking me about it. So far, every one of my pulmonary clinic patients tells me (both with and without covid) that they want the vaccine. And I’m happy when they tell me that. And I tell them pretty much everything I said in my last video. And pretty much everything I’m going to tell you in this video.
Fresh off of FDA Authorization, EUA, that is, the Pfizer/BioNTech vaccine has finally arrived. The CDC has given the green light for the vaccine, and it is being shipped right now. And I’ll be getting it in a few days, along with my colleagues. Most people don’t realize just how big of a deal this really is. Not just because of the current situation we’re in. This vaccine, this mRNA vaccine, has never been done before. The technology to make an mRNA vaccine began back in 2002 with the first SARS virus.
Pfizer Vaccine for COVID
But this vaccine, from the time of conception to the time of getting EUA from the FDA – less than a year. This is a historic moment. Looking back in history, this will be a medical breakthrough moment. Because not only is it 1st of its kind, it’s 95% effective. And it’s very safe. And it is the key to shutting down the virus. Scientific and public health experts ensured that this vaccine underwent rigorous scientific standards for safety, effectiveness, and manufacturing quality to support emergency use authorization.
It’s a HUGE testament to scientific and medical innovation. And we can expect 20 million people to get vaccinated in the next few weeks – that being health care workers and people living in long-term care facilities like nursing homes. We are talking about Pfizer and BioNTech vaccine, which goes by the scientific name BNT162b2. It’s an mRNA vaccine, meaning messenger RNA. In a lab, a tiny piece of genetic material is made.
This genetic material called mRNA is a specific genetic blueprint that tells the body’s cells to make a particular protein. It’s the same protein as the spike protein of the coronavirus. Once the cells make that protein, the immune system recognizes it as foreign. Hence, the immune system, in response, develops antibodies to fight against the protein, which means it will fight against the coronavirus.
The vaccine is given in 2 separate doses, 21 days apart. The first dose is to prime the body; the second dose is to boost the response. There were 43,000 total people in the study, age 16 and older. Half of them received a placebo; the other half received the vaccine. Only eight Covid cases among people who received the vaccine, compared with 162 cases among those given the placebo.
There was 95% efficacy in people ages 16 and older. And almost 100% effective at preventing severe COVID disease. Of all the 21,720 people who got the vaccine, only 1 developed severe COVID. If you look at the placebo group, there were 9 cases of severe COVID. When the groups were analyzed by age, sex, race, ethnicity, obesity, and presence of a coexisting medical condition, the vaccine’s efficacy rate remained consistent. Some people wonder, is the 1st dose enough? The short answer is no, but it does provide some protection between the first and second doses, the vaccine efficacy of 52%. This is why the booster dose is still necessary.
Severe systemic events were reported in less than 2% of vaccine recipients after either dose, except for fatigue (in 3.8%) and headache in 2% after the second dose. None of the people who received the vaccine died or required hospitalization or a trip to the ER. People who developed symptoms related to the vaccine…this is called vaccine reactogenicity…meaning side effects that occur due to the body’s immune system reacting to the vaccine. And reactogenicity is categorized as local reactogenicity, meaning the location of the injection site in the arm.
The people who did get symptoms included injection-site pain and redness, fever, fatigue, and enlarged lymph nodes. Symptoms were more common after the second dose and more common in younger people. And then there is systemic reactogenicity, things like fever, fatigue, headache, and the like. Overall, most people who got the vaccine did just fine, without symptoms.
The vast majority of the patients who did get symptoms only had mild to moderate symptoms that lasted no more than a day or two. Overall, there is insufficient data to make conclusions about the vaccine’s safety in subpopulations such as children under 16 years of age, pregnant and breastfeeding women, and immunocompromised people. If someone has a history of a severe allergic reaction, it’s probably better for them to hold off on getting the vaccine for now, only because there is not enough data in the study to know for sure.
Doctor Mike Hansen, MD
Internal Medicine | Pulmonary Disease | Critical Care Medicine