Tip/Thought of the Day

Covid-19 Emergency Vaccine Approval- Here’s What To Know

This past week, the Food and Drug Administration (FDA) authorized emergency use of the coronavirus vaccine developed by both Pfizer-BioNTech. Since the beginning of the pandemic, companies have raced to develop, run trials, and pass the rigorous approval process set forth by the FDA in an effort to overcome the pandemic. Covid-19 has already killed almost 300,000 Americans, caused serious harm to countless others, and is still spreading rampantly throughout our country as we speak. It is no surprise that the mix of heightened caution, the speed at which the vaccines were developed, mixed with a mountain of misinformation has now led to many wondering if the vaccines are safe. In today’s post we’ll share some information about the development and safety, and availability of the vaccines.

Development

Currently there are at least 48 vaccines being tested in experiments with human volunteers, and another 164 that are being studied in a laboratory. The effort to provide the best protection with the least amount of side effects. Across the board, it is unknown how long the protection lasts, with some speculating it is roughly 3-4 months.

Companies have taken divergent approaches in developing vaccines; Pfizer and Moderna use some of the virus’s genetic material and introduce it into the body without administering any actual viral components. This approach, using a type of molecule called messenger RNA, has never before been approved. But according to experts, using a naturally occurring molecule is a source of reassurance.

“It is a new type of vaccine, but remember, we all have messenger RNA in our body,” said Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia and a member of the FDA’s advisory panel. “It’s not like it’s a novel molecule — it’s a molecule that we all see.” Rest assured- if you receive the vaccine, you will not be injected with live virus. The vaccine works by training the body into responding as though it has been compromised. If and when you are exposed to Covid-19, your body will already have “learned” how to respond to the threat, and produces antibodies that protect you from the virus.

In recent weeks, pharmaceutical giants Pfizer and Moderna published data showing their vaccines to be more than 90% effective, which is more effective than many thought was possible.

The FDA advisory panel charged with reviewing the most recent evidence and trial results approved usage of the Pfizer vaccine for those over 16 years of age. Three individuals (of twelve) on the advisory board voting against approval because of very limited information on how the vaccine may impact those children aged 16-17. When it comes to children under 16 years of age and the vaccine, the concern lies in the lack of clinical trials yet to be completed. Pfizer-BioNTech, expanded its COVID-19 vaccine testing to children ages 12 and older only in October. Moderna announced on Dec. 2 that it planned to begin COVID-19 vaccine trials with children ages 12-17 soon. Promising though, is that so far no serious safety concern have been identified with either Pfizer or the Moderna vaccines- but the trials have just started. Yet, overwhelmingly, scientists agree that the benefits and protection that the vaccine provides outweighs the potential side effects.

According to the CDC, pregnant women who have COVID-19 appear more likely to develop respiratory complications requiring intensive care than women who aren’t pregnant. Pregnant women are also more likely to be placed on a ventilator. These are serious factors to weigh when considering whether pregnant women should receive the vaccine. The FDA stated that while trials have not involved pregnant women, they would not preclude them from receiving the vaccine with advisement from providers. Additional developmental and toxicity studies were ordered to further understand potential side effects and general safety for pregnant and lactating women.

Dosage and side effects

The Pfizer-BioNTech COVID-19 Vaccine is administered as a 2-dose series, 3 weeks apart, into the muscle. The vaccine has an efficacy rate of 52% between the first and second dose, according to the data assessed by the FDA. The efficacy of the vaccine climbs to 95% seven days after the second dose. While there is protection offered with just a single dose, the vaccine was created with the structure of the two-doses in mind, making it essential to receive both doses for maximum protection.

According to the FDA the most commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever. More people experienced these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose.

The FDA goes on to share that there is a remote chance that the Pfizer-BioNTech COVID-19 vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the vaccine. Signs of a severe allergic reaction can include:

• Difficulty breathing

• Swelling of your face and throat

• A fast heartbeat

• A bad rash all over your body

• Dizziness and weakness

Availability

Sunday afternoon, the first of the vaccine shipments left Pfizer’s Michigan and Wisconsin plants. Pfizer is expected to deliver an estimated 2.9 million doses this week via UPS and FedEx. While the carriers usually compete for business, they have partnered together to take on the giant task of delivering the vaccine nationwide. The vaccines, have U.S. marshal protection to ensure they arrive safely at the hospital systems selected to receive the doses, some as early as Monday.

You can read here for specifics on how many doses will reach your state.

The CDC has put together an advisory panel, named the The Advisory Committee on Immunization Practices, which has recommended that the nation’s 21 million health care workers be eligible for the vaccine before anyone else, along with three million mostly elderly people living in nursing homes and other long-term care facilities.

A New York Times investigation into the process revealed that 39 % of deaths from the coronavirus have occurred in long-term care facilities. But there won’t be enough doses at first to vaccinate everyone in these groups; Pfizer and Moderna have estimated that they will have enough to vaccinate no more than 22.5 million Americans by January. So each state will have to decide which health care workers go first.

The CDC goes on to suggest that essential workers, those unable to work remotely from home- leaving them more vulnerable due to possible repeated exposure to the virus- be next to receive the vaccine. About 87 million Americans are deemed “essential”, working in food and agriculture, manufacturing, law enforcement, education, transportation, corrections, emergency response and other sectors.

Next, adults with medical conditions that put them at greater risk for severe Covid-19 would be eligible, followed by any remaining adults. It is unknown where in the mix children may be included, as studies including younger children have just started. Several sources say that estimates show that by May or June of next year is when the vaccine should be widely available outside of the priority groups. To learn more about some common FAQs, you can read here , additional info from the CDC, here, and from the FDA, here.


Regardless of the timing, the only way we will conquer this virus, stop the deaths, long-term effects from the illness, and restore our lives and economy will be when these life saving vaccines get into the arms of every American. It requires participation from 60-70% of the entire country or the value to all of us will not be seen. 

I am often asked by my patients if I will get the vaccine. My answer: I would eagerly take the vaccine tomorrow if given the opportunity. When that day comes, I will happily relate how it felt and any issues I have.

Stay tuned for more updates to come.



Sources:

-reuters.com/article/uk-factcheck-covid19-vaccine-hiv-cancer/fact-check-posts-critical-of-fast-covid-19-vaccine-development-make-misleading-comparison-to-hiv-cancer-common-cold-idUSKBN28L2CF

-nytimes.com/2020/12/01/health/covid-vaccine-distribution-first.html

-bostonglobe.com/2020/12/09/nation/one-dose-pfizers-covid-19-vaccine-offers-some-protection-experts-say-you-still-need-second-shot/

-abcnews.go.com/Health/things-covid-19-vaccines/story?id=74591998

-theconversation.com/when-can-children-get-the-covid-19-vaccine-5-questions-parents-are-asking-150721

-fda.gov/media/144414/download

-nature.com/articles/d41586-020-02684-9

-nbcnews.com/news/us-news/first-trucks-covid-19-vaccine-roll-out-pfizer-plant-michigan-n1251037

-abcnews.go.com/Health/covid-19-vaccines-work/story?id=73796121

-cidrap.umn.edu/news-perspective/2020/12/fda-panel-oks-pfizer-covid-vaccine-emergency-use

-fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine

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