Pfizer Plan for COVID Booster Shot Raises Safety Concerns

Pfizer Plan for COVID Booster Shot Raises Safety Concerns

Opinion | On July 8, 2021, Pfizer, Inc. announced it was developing a booster dose for its experimental messenger RNA (mRNA) BNT162b2 biologic for COVID-19. It said that it had observed waning immunity among people who received the standard two-dose regimen of the product. The company said it planned to begin clinical studies of the third shot as early as August and would seek emergency use authorization (EUA) for the third doze from the U.S. Food and Drug Administration (FDA).1 2 In a written statement to CNN, Pfizer said:

As seen in real world data released from the Israel Ministry of Health, vaccine efficacy in preventing both infection and symptomatic disease has declined six months post-vaccination, although efficacy in preventing serious illnesses remains high. Additionally, during this period the Delta variant is becoming the dominant variant in Israel as well as many other countries. These findings are consistent with an ongoing analysis from the Companies’ Phase 3 study.1 2

Pfizer added:

While protection against severe disease remained high across the full six months, a decline in efficacy against symptomatic disease over time and the continued emergence of variants are expected. Based on the totality of the data they have to date, Pfizer and BioNTech believe that a third dose may be beneficial within 6 to 12 months following the second dose to maintain highest levels of protection.1 2

Pfizer’s proposal for a booster dose came on the heels of a finding by Israel’s Ministry of Health that BNT162b2 has proven to be only 64 percent effective in preventing symptomatic infections of COVID-19. The 64 percent rate is much lower than the 95 percent efficacy rate reported by Pfizer during the clinical trials for its product last year. This would, at least in part, explain why nearly half of the people in Israel being infected with coronavirus are those who have been fully vaccinated. The Pfizer/BioNTech shot is simply not providing the kind of high level of protection that was initially advertised.3 4

FDA, CDC and WHO Push Back on Booster Proposal

Within hours of the release of the Pfizer statement, the FDA and Centers for Disease Control and Prevention (CDC) issued a joint statement saying a third dose of the Pfizer/BioNTech biologic was not needed.1 5 6 According to the statement:

Americans who have been fully vaccinated do not need a booster shot at this time. FDA, CDC, and NIH are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary. This process takes into account laboratory data, clinical trial data, and cohort data–which can include data from specific pharmaceutical companies, but does not rely on those data exclusively. We continue to review any new data as it becomes available and will keep the public informed. We are prepared for booster doses if and when the science demonstrates that they are needed.ed.6

On July 11, Anthony Fauci, MD, White House medical adviser and director of the National Institute of Allergy and Infectious Diseases (NIAID), expressed support for the FDA/CDC position on a Pfizer/BioNTech booster.7 Dr. Fauci noted:

Given the data and the information we have, we do not need to give people a third shot, a boost, superimposed upon the two doses you get with the [Pfizer/BioNTech and Moderna/NIAID] mRNA [biologics] and the one dose you get with [Johnson & Johnson]. … There’s a lot of work going on to examine this in real time to see if we might need a boost. But right now, given the data that the CDC and the FDA has, they don’t feel that we need to tell people right now you need to be boosted.7

On July 12, representatives of Pfizer met in private with FDA and CDC representatives regarding the proposal for a booster shot. Pfizer shared preliminary data on its ongoing trials to develop a booster dose. The company characterized the meeting as “productive” and said that the participants agreed that “scientific data will dictate next steps.”8 9

It was an interesting meeting. They shared their data. There wasn’t anything resembling a decision,” Dr. Fauci said.8

The World Health Organization (WHO) has also come out in opposition to Pfizer’s call for a booster dose. “The priority now must be to vaccinate those who have received no doses and protection,” said WHO director-general Tedros Adhanom Ghebreyesus.

The chief scientist for the WHO, Soumya Swaminathan, MD said, “At this point, there is no scientific evidence to suggest that boosters are definitely needed,” adding that the WHO would decide on the need for booster shots “based on the science and data, not on individual companies declaring that the vaccines should now be administered as a booster dose.”10 11

CDC Says Booster May Pose Higher Risk of Serious Side Effects

One of the worries expressed by CDC officials regarding a third dose has to with safety—that the additional shot could come with greater risk. On July 13, Jay Butler, MD, the deputy director for infectious diseases at the CDC said:

The risk of some of the rare side effects that have been reported have been greater after the second dose, and even just the local reactions which are fairly common, are more common after the second doses as well. So we’re keenly interested in knowing whether or not a third dose may be associated with any higher risk of adverse reactions, particularly some of those more severe, although very rare, side effects.12

There is also some question about the safety of “mixing and matching” shots. For example, if a Pfizer/BioNTech booster shot was available, would it be safe to give it to people who had previously received Moderna/NIAID’s experimental mRNA-1273 biologic or Johnson & Johnson’s experimental Ad26.COV2.S vaccine for COVID-19? The CDC says that COVID-19 vaccines are not interchangeable.13

The CDC has stated clearly that if you receive a Pfizer/BioNTech or Moderna/NIAID biologic, “you should get the same product (or brand) for your second shot.” Logically, this recommendation would extend to a third shot, a booster.13

Dr. Swaminathan has warned that mixing and matching COVID-19 vaccines is a “dangerous trend.” She says, “We’re in a data-free, evidence-free zone as far as mix-and-match. There is limited data on mix-and-match,” adding… “Data from mix and match studies of different vaccines are awaited—immunogenicity and safety both need to be evaluated.”14


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Note: This commentary provides referenced information and perspective on a topic related to vaccine science, policy, law or ethics being discussed in public forums and by U.S. lawmakers.  The websites of the U.S. Department of Health and Human Services (DHHS) provide information and perspective of federal agencies responsible for vaccine research, development, regulation and policymaking.

Click here to view References:

1 Fox M. Pfizer says it’s time for a Covid booster; FDA and CDC say not so fast. CNN July 9, 2021.
2 Lovelace B. Pfizer says it is developing a Covid booster shot to target the highly transmissible delta variant. CNBC July 8, 2021.
3 Linnane C. Israel says Pfizer vaccine just 64% effective in real world as delta variant continues to spread rapidly. MarketWatch July 6, 2021.
4 Cáceres M. Highly Vaccinated Israel Has a Nagging Coronavirus Problem. The Vaccine Reaction July 4, 2021.
5 Hein A. Americans ‘do not need’ COVID-19 booster shot, FDA, CDC say. Fox News July 9, 2021.
6 Press release. Joint CDC and FDA Statement on Vaccine Boosters. U.S. Department of Health and Human Services July 8, 2021.
7 Stracqualursi V. Fauci says Americans who are fully vaccinated do not need booster shots at this time. CNN July 11, 2021.
8 Stolberg SG, LaFraniere S. U.S. Officials Press Pfizer for More Evidence of Need for Booster Shot. The New York Times July 12, 2021.
9 Nathan-Kazis N.  Pfizer Met With Government Scientists. Approval of a Booster Dose Is No Closer. Barron’s July 13, 2021.
10 Sullivan P. Pfizer sparks thorny debate over COVID-19 booster shots. The Hill July 14, 2021.
11 Helmore E. Pfizer pushes for US booster shots as WHO says greed is driving vaccine disparities. The Guardian July 12, 2021.
12 O’donnell C, Maddipatla M. U.S. health official says COVID-19 boosters could risk more serious side effects. Reuters July 13, 2021.
13  U.S. Centers for Disease Control and Prevention. Getting Your COVID-19 Vaccine. June 23, 2021.
14 VanHoose B. WHO Scientist Cautions Against Mixing and Matching COVID-19 Vaccines, Calls It ‘Dangerous Trend’. People July 13, 2021.

Pfizer Plan for COVID Booster Shot Raises Safety Concerns

13 Responses to "Pfizer Plan for COVID Booster Shot Raises Safety Concerns"

  1. John   July 19, 2021 at 4:39 pm

    We knew it was only experimental. If it didn’t work the first time they will just keep shooting the fool until they get it right….or NOT.

    Reply
    • Ant   July 19, 2021 at 8:36 pm

      Ur a little to smart for the market of total bs

      Reply
  2. Pat   July 19, 2021 at 4:51 pm

    Of course they don’t need a booster. One kill shot is enough. Massive deaths will start in the fall. No booster needed, no need to expend the money and resources to provide it. And I think they’re starting to feel the backlash. They’re not going to admit the shots are deadly. But hopefully it will stop the FDA from licensing these horrible shots.

    Reply
  3. Tom   July 19, 2021 at 4:52 pm

    Where were the safety concerns for the initial rollout of injections? Now that 10’s of thousands have died after their injections, there is still no concern in the least. In the end big pharma will force their will on government because immediate profits and thinning of populations are the agenda number one. Safety and efficacy are not even on their list and never have been and never will be.

    Reply
  4. suss   July 19, 2021 at 4:55 pm

    The sheep will line up for the new kill booster, no doubt about it!!!! Very dark days ahead to be sure!

    Reply
  5. Rick   July 19, 2021 at 4:59 pm

    Perhaps a clinical trial for a third dose of the Pfizer “vaccine” should be conducted with Pfizer executives and marketing people as the test subjects. Wonder how many have gotten the first two shots?

    Reply
  6. Catherine M. Allegretti   July 19, 2021 at 5:29 pm

    We have a consumer need/commitment to follow the science. Dr. Fauci will be on top of the current findings. It is best to have one particular source. Unless there is an M.D. or PhD following your signature! Then you may have additional avenues.

    Reply
  7. Susan   July 19, 2021 at 5:57 pm

    “Rare” side effects…what a load of hooey. Even the deaths aren’t rare. It’s nothing more than a death shot.

    Reply
  8. Mary Byrnes   July 20, 2021 at 8:01 am

    How many deaths from the Covid 19 shots has there been any in the US?

    Reply
    • Maria   July 20, 2021 at 7:10 pm

      This info is free provided by the CDC in VAERS (Vaccine Adverse Event Reporting System). Note that they make the website difficult to maneuver and understand, it took me an hour to filter for the info I wanted. Also note that only about 5% of reactions are ever reported. Additionally, the CDC changed the rules so that only people hospitalized from a reaction to the covid vax are required to be reported. All of this to dilute the numbers but the numbers are out there for public view. It’s just no one wants to see it. I just did a quick search today and in 2020 50 deaths, 2021 5,362 deaths and another 498 died at an unknown date. 427,000 didn’t die but had some type of reaction. Now multiply these numbers by 20 or to be conservative, 10 to get the full scope of what is really happening; only about 5% are reported. This is just the USA. https://wonder.cdc.gov/vaers.html https://vaers.hhs.gov/data.html

      Reply
  9. Ron S   July 21, 2021 at 6:04 pm

    Pfizer cares more about $ than lives. They could have replaced the 2 💉 jab with the new varriant. But they wouldn’t sell more vaccinees

    It won’t work the shot 💉 is to deadly.
    and we get s new varriant every 4 months.

    Reply
  10. Ro   July 22, 2021 at 3:36 pm

    This is the most outrageous and mentally ill thing I have ever seen in my entire life! They have no liability and they see people as a source of cash cows! It makes me sick and I think that primary prevention is the best especially when you consider it is 98 percent non lethal. Why do we need to fill our bodies full oc chemicals and shorten or end our lives!

    Reply
  11. Cynthia VanOrden   July 23, 2021 at 10:00 am

    Are the people of Chy na getting these shots? Are they getting pfizer shots? Have they gotten 2 shots? What is THEIR death toll from the shots????

    Reply

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