Category Archives: Emergency Use Authorization

Which COVID Vaccine

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The best COVID-19 vaccine for you is the vaccine you can get in your arm the soonest. 

There are three vaccines approved for emergency use by the Food and Drug Administration and some people are tempted to shop around. Some people may want the convenience of the Johnson & Johnson single-dose shot and its low rate of side effects. Others may be interested in the extremely high efficacy of the Pfizer and Moderna two-shot mRNA vaccines.

Which Covid vaccine is best for you? It's the one you can get the soonest.

Bottom line: You should get the vaccine that’s available soonest. All three vaccines approved for emergency use have been shown to be safe and effective against severe complications of COVID-19, the disease caused by the novel coronavirus SARS-CoV-2, according to the Centers for Disease Control and Prevention.

In clinical trials, all three vaccines prevented hospitalizations and death, the worst outcomes of the virus. While these were not the primary outcomes measured (symptomatic infections were), this effectiveness continues to play out in post-vaccination studies. Very few people who have been fully vaccinated are getting sick and even fewer are hospitalized.

All three vaccines produce side effects in patients — but not all patients. Although, there are slight differences in side effects. People who get the J&J vaccine tend to experience fewer of them, but each vaccine produces side effects, mostly mild, in some patients. These side effects are short-lived.

The most common side effect is pain, redness or swelling at the injection site. Other people experienced tiredness, headache, muscle pain, chills, fever or nausea. But most of these side effects were mild to moderate and went away quickly.

Remember, these side effects are a sign that your body is reacting to the vaccine and building immunity to the virus (if you don’t have side effects, that doesn’t mean the vaccine isn’t working), according to Dr. Andrea Klemes, the Chief Medical Officer of MDVIP. They’re a small price to pay to get that protection. They’re also rarer in the general population than they were in clinical trials participants with a higher frequency after the second dose. About 372 out of every million administered doses of the Moderna and Pfizer vaccines lead to a non-serious reaction report, according to the journal Nature. The most frequently reported side effects are headache (22.4%), fatigue (16.5%) and dizziness (16.5%), according to the Centers for Disease Control and Prevention.

The bottom line: You’ve waited this long for the vaccine; you shouldn’t shop around when the opportunity to get the vaccine presents itself. The faster everyone gets vaccinated, the faster we will be able to return to normal.

References:

  1. https://www.mdvip.com/about-mdvip/blog/which-covid-vaccine-should-you-get
  2. https://www.cdc.gov/mmwr/volumes/70/wr/mm7008e3.htm

Johnson & Johnson Vaccine

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A single-shot coronavirus vaccine from pharmaceutical giant Johnson & Johnson was effective at preventing illness, hospitalizations and deaths in global trial. But its protection against sickness was stronger in the United States and weaker in South Africa, where a worrisome coronavirus variant now dominates.

The results, once granted emergency use authorization by the FDA, would put a third vaccine on the market in the United States. A third vaccine could accelerate the ability to broaden immunity, as variants that challenge the current generation of vaccines spread across the world.

The vaccine trial was primarily designed to measure how well the vaccine prevented illness. It was 66 percent effective overall at preventing moderate and severe disease: it was 72 percent effective at protecting against moderate to severe illness in the United States, but it was 66 percent effective in Latin America and 57 percent effective in South Africa, where concerning variants have taken root.

Company officials emphasized the vaccine was 85 percent effective at preventing severe illness, and there were no cases of COVD-related hospitalization and death in people who received the vaccine. There were five COVID-related deaths in the trial, all in people who received the placebo, not the vaccine.

Johnson & Johnson is expected to apply for emergency use authorization from the Food and Drug Administration late next week. If the review follows the path of two earlier vaccine candidates, the shot could be authorized and available to the public by March.

The J&J vaccine uses a different technology than the two FDA  authorized mRNA vaccines. This vaccine employs ‘a harmless cold virus’ to deliver a gene that carries the blueprint for the spiky protein found on the surface of the coronavirus. The virus infects cells, which then follow the genetic instructions to construct a replica of the coronavirus spike.

In contrast, the Pfizer and Moderna vaccines use a strip of genetic material called messenger RNA to instruct cells to build the spiky protein found on the surface of the coronavirus. In both cases, the immune system learns to recognize the real virus by mustering an immune response to the spike.

References:

  1. https://www.washingtonpost.com/health/2021/01/29/covid-vaccine-johnson-and-johnson
  2. https://www.washingtonpost.com/health/2020/09/23/coronavirus-vaccine-jj-single-shot/?itid=lk_inline_manual_2

mRNA Vaccine Safe and Its Side Effects

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Moderna and Pfizer COVID-19 vaccine trials show that side effects are common in participants and it appears that the more significant symptoms develop following the second dose.

The Pfizer-BioNTech’s mRNA coronavirus vaccine (BNT162b2) is both safe and effective, according to the U.S. Food and Drug Administration (FDA). FDA said results from Pfizer’s large, ongoing study showed the vaccine, which was co-developed with Germany’s BioNTech, demonstrated more than 95% efficacy across people of different ages, races and underlying health conditions, including diabetes and obesity. And partial protection from coronavirus appears to begin 12 days after the first dose, according to Pfizer. Consequently, Pfizer requested and the vaccines are expected to be approved for emergency use authorization (EUA) by the FDA as early as this week.

And this week, a committee of leading U.S. vaccine scientists recommended that the Food and Drug Administration authorize the first COVID-19 vaccine for Americans.

FDA approval of a drug means that the agency will have determined, based on substantial evidence, that the drug is effective for its intended use, and that the benefits of the drug outweigh its risks when used according to the product’s approved labeling. Approval of the he vaccine will help reduce the risk of disease. The vaccine works with the body’s natural defenses to safely develop protection (immunity) to disease, according to the FDA’s website.

How an mRNA vaccine works

Messenger RNA vaccines, called mRNA for short, is a new kind of vaccine technology that has never before been licensed in the U.S. mRNA vaccines contain material from the virus that causes COVID-19 that gives our cells instructions for how to make a harmless protein that is unique to the virus. The objective of a vaccine is to teach your immune systems how to recognize and fight the virus that causes COVID-19, according to the Centers for Disease Control and Prevention.

Messenger RNA vaccines aren’t like past seasonal influenza vaccines. An mRNA vaccine is essentially just a piece of genetic code that contains instructions for our body. The mRNA tells our cells to make a protein — the same protein that is the spike on top of the actual coronavirus. This is what triggers the immune response in these types of vaccines.

In contrast, past seasonal influenza vaccine puts a weakened or inactivated virus into your body to trigger an immune response, which then produces antibodies. Those antibodies are what ultimately protects you from getting infected if you ever encounter the real virus.

It typically takes a few weeks for the body to build immunity against COVID-19 infection after vaccination. And after vaccination, the process of building immunity can cause symptoms or “side effects”. These symptoms are normal and are a sign that the body is building immunity.

Side effects

Sometimes the vaccine process of teaching your immune system how to react to the virus can cause symptoms. These symptoms are normal and are a sign that the body is building immunity. Moreover, no major safety issues were uncovered and common vaccine-related side effects like fever, fatigue and injection site pain were tolerable, according to the FDA.

The most common vaccine side effects were injection site reactions (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), and fever (14.2%), acc riding to the report submitted to the FDA.

Severe adverse reactions occurred in 0.0% to 4.6% of participants and appeared were more frequent after the second dose than after the first. The frequency of serious adverse events was low (<0.5%), without meaningful imbalances between study arms.

Although some COVID-19 trial participants reported COVID-like symptoms, it is impossible to contract the coronavirus from the vaccine, because the mRNA vaccines develop by Pfizer and Moderna don’t use the live virus. 

Bottomline

Getting vaccinated is one of many steps you can take to protect yourself and others from COVID-19.  Vaccines work with your immune system so your body will be ready to fight the virus if you are exposed.

References:

  1. https://www.cnbc.com/2020/12/08/pfizer-moderna-covid-vaccine-side-effects-trials.html?__source=iosappshare%7Ccom.microsoft.msedge.EMMXShareExtension
  2. https://www.fda.gov/media/144245/download
  3. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/how-they-work.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fvaccines%2Fabout-vaccines%2Fhow-they-work.html
  4. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits/facts.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fvaccines%2Fabout-vaccines%2Fvaccine-myths.html