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FDA Says Pfizer BioNTech Vaccine Is Safe

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Coronavirus vaccine jointly developed by Pfizer and BioNTech that is used for the prevention, immunization and treatment of Coronavirus - Covid-19-pfizer biontech vaccine-ss-featured

The FDA declared the Pfizer BioNTech vaccine is safe and effective for coronavirus. According to a Food and Drug Administration review, the vaccine “met the prescribed success criteria” in a clinical study. Also, the report said that there are no specific safety concerns that can prevent the agency from issuing a green light. This means that approval for emergency use authorization is very likely to come out as early as this weekend.

RELATED: BioNTech, Pfizer Covid Vaccine Will Seek FDA Approval 

On December 10, an outside panel of scientific advisers will review the FDA report. They will also look into the analysis prepared by Pfizer Inc. and its German partner BioNTech SE. If they agree with the FDA’s findings, expect the issuance of a EUA within the next few days.

Emergency Use Authorization

The 53-page downloadable document contains the latest data from both the FDA and the manufacturers. It extensively covers the Phase 3 clinical trials and will serve as the main source of information for the advisory group’s decision. 

Independent reviews outside of the FDA started coming in with positive feedback. One such expert is Dr. William Moss, the executive director for the Johns Hopkins Bloomberg School of Public Health International Vaccine Access Center. He said that he thinks “we can be confident in the findings of this trial.” Moss noted the extensiveness of the study, and that the effective rate translates well across various ethnic, racial, and age groups. Dr. Greg Poland, director of the Mayo Clinic’s Vaccine Research Group, agrees. Based on the report, he sees “absolutely no reason why this emergency use authorization would not be granted.”

First Injection

Part of the FDA report includes its findings for the vaccine’s effectiveness. The vaccine requires two doses given 21 days apart to receive the full effect. However, the agency noted that the vaccine already showed effectiveness even after the first dose. Immediately after the first shot, the risk of coronavirus reduces by 50%. After the second dose, effectiveness shoots up to 95%. 

FDA’s findings also confirmed that the vaccine reduces the risk of acquiring a severe form of COVID-19. This development helped assuage health officials who feared that the vaccine can only protect against the mild forms of the disease. 

Side Effects

Pfizer BioNTech’s coronavirus vaccine is not without side effects. The FDA report said that side effects are common, especially among the younger set. They consist of fatigue, muscle pain, or joint pain. Participants also reported cases of headaches, chills, and fever. In addition, there were cases of severe “adverse reactions,” but these are mostly rare occurrences. And, they happened much less frequently in adults older than 55 years. 


The side effects signify that the body is reacting to the vaccine. After all, a strong immune response is what immunologists hope for after an inoculation. Dr. Angela Rasmussen, a virologist at the Center for Global Health Science and Security, advises preparing for the shots. 

She said that “It doesn’t mean the vaccine is making you sick, but you should be prepared for potentially not feeling great for a day or two after getting it.”

Questions for Future Reference 

Vaccines usually undergo clinical trials for longer periods of time. For coronavirus vaccines, the process needed expediting given the current damage of the virus to people’s health and the economy. While this helps get quicker approval, some questions will need answering later on. 

First, the vaccine’s effect on children, pregnant and breastfeeding women will need more studies. The same applies to people with compromised immune systems. Also, questions arose from the effectiveness period of the vaccine. How long does a vaccine remain effective in the human body? How often should people get vaccines? And finally, can vaccinate people still get the virus and transmit it to others? These are questions whose answers will have to wait a little while longer.

How Many Will Be Available This Year?

If the independent review will confirm that the Pfizer BioNTech vaccine is safe, expect an immediate rollout by the US government. Thanks to Operation Warp Speed, the US will receive a guaranteed 100 million doses from Pfizer BioNTech. The companies expect around 50 million doses available for this year, with another 1.3 billion in 2021. 

However, it remains very unlikely the US will receive all 100 million within days of a EUA. HHS Secretary Alex Azar expects around 6 million doses of Pfizer’s vaccine to arrive this month. This is enough to complete vaccinations for 3 million people. According to earlier plans, Medical workers and the elderly will get priority over the vaccines as well. Government officials estimate that vaccinations for the entire American population will take place by the 2nd quarter of 2021.

Watch the CBS News report on the FDA’s confirmation that the Pfizer BioNTech vaccine is safe and effective:

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Do you agree that the Pfizer BioNTech vaccine is safe and that it deserves a EUA? Will you trust it enough to get a vaccine within the next few months? Let us know what you think by leaving your comments below.

13 Comments

13 Comments

  • Gerald says:

    If it’s safe then those in Congress should take it first!

  • charles says:

    The FDA, a government agency, the political party, rich elites or whomever pays the most. Big money wins.

  • William woods says:

    If it helps save a life then it is worth everything. Of course it will not save everyone but if you are the one it saves need i say more.

  • Gary Carvella says:

    FDA has changed its mind many times. SAFE??? The flue vaccine still has not been proved safe. people still get the Flu and the formula gets changed every season.
    What about the other company??or has Pfizer paid more to the FDA for approval. ???

  • Government Rat says:

    The CV-19 mRNA vaccine has been labelled a BIOWEAPON and no one should take it.Everyone must reject the vaccine en masse.No one should trust the word of ANY U.S. government agency,especially the FDA.For decades the FDA has lied repeatedly about the safety and efficacy of vaccines.Congress gave big pharma immunity from lawsuits.The U.S. government has a secret payout to give millions to those who have been harmed or killed by big pharma’s poisons.

  • cheryl Jean lorditch says:

    no, we do NOT need a 14 wk old dead embreyo dna in our blood… I would rather deal with covid than a tainted vaccine that was rushed to make and they have NOT made a safe corona vaccine in 30 years so what makes you think this is safe?????

  • Anonymous says:

    Until the virus is 100% under control, studies should continue.

  • Doye Ward Jr. says:

    I thank the way people are dieing then we all should try it cause if if you get the virus you have a 50/50 chance anyways so if it not killing people the way the virus is why not take it it is 50/50 either or

  • Anonymous says:

    This is the same vaccine that has caused severe allergic reactions to people in Ireland but nothing has been said about that here in the states? So yeah as for my children and myself will not be excepting this

  • Anonymous says:

    I as an American citizen , given my freedom, should have the right to not take any vaccine! If you are a person who believes you should take it then take it. I will not

  • Anonymous says:

    Nobody knows what long term effect the vaccine might have on the body either

  • James Smitj says:

    After the demorat cheat and fraud party, I don’t trust any government agency, in my eyes they are all crooked and liars. They all think their civil servant status entitles them to pillage and loot taxpayers dollars at will. “There’s money to be made here Senator, money to be made‼️”

  • Anonymous says:

    Let’s see how it affects the first million people who receive it. Then determine if it’s truly safe. CDC says any vaccine has a 1-3% injury or fatality issue. Not a big number considering, unless you or your loved one is in that 1-3%. Then it is your finances caring for the damage done!! No pharma or agency is out there to help with long term therapy and care. So think first!!!
    When viagra was new it was sold as a miracle, but no science/fda/pharma company ever revealed the dangers of viagra used by patients who also used nitroglycerin. Dangerous BP issues and death. That’s pretty funny to think you have med to stave off heart pain but will die from your hard on!! So the first year or so we had patients in ER with dangerous situations and no explanations

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