Pfizer and Moderna will begin clinical trials to determine adverse heart risks from COVID-19 vaccines, such as myocarditis



The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine on Dec. 11, 2020. A week later, the FDA issued an EUA for Moderna's COVID-19 vaccine. Now, nearly two years later, Pfizer and Moderna will launch clinical trials to track adverse health issues stemming from the COVID-19 vaccines, such as myocarditis – inflammation of the heart muscle.

Pfizer is in the infancy of beginning clinical trials to determine if there are any health risks associated with their own vaccine. In a partnership with the Pediatric Heart Network, the trial will focus on vaccine recipients who have suffered heart issues following being jabbed with the COVID-19 vaccine. The clinical trials will monitor patients for five years.

Enrollment for the study in the U.S. and Canada has not started yet. However, the research team has already identified more than 250 patients with myocarditis, according to Dr. Dongngan Truong – a pediatrician at the University of Utah Health and a co-lead on the Pfizer study.

NBC News reported on Friday, "The team will also compare the patients to a subset of patients with multisystem inflammatory syndrome in children, also known as MIS-C, which is associated with a COVID infection."

The first findings are not expected to be released until sometime next year.

Moderna will be conducting their own studies about possible side effects of the COVID vaccines in five countries with the assistance of the European Medicines Agency. The data from those studies are not expected to be released to the public until next summer.

Dr. Paul Burton – Moderna's chief medical officer – admitted that scientists are not certain as to what causes the possible heart issues from the COVID-19 vaccine.

“We don’t understand yet and there’s no good mechanism to explain it,” Burton conceded to NBC News.

Burton theorized that the spike protein in the vaccine may stimulate a negative reaction in the body that could cause inflammation in the heart.

NBC News highlighted the alarming struggles of one Michigan man who suffered major health issues after receiving a COVID vaccine.

In October 2021, Detroit native Da’Vion Miller was found unconscious in the bathroom of his home one week after receiving his first dose of Pfizer's COVID-19 vaccine. Miller, who was only 22 years old at the time, experienced chest pain two days after getting vaccinated. He also suffered from fatigue, dizziness, and shortness of breath.

Miller was rushed to the Henry Ford West Bloomfield Hospital, where he was diagnosed with myocarditis and pericarditis – inflammation of the outer lining of the heart.

Miller's doctor advised him not to receive his second dose of the COVID vaccine.

In the year since being diagnosed with myocarditis, Miller is still experiencing chest pain and has been in and out of the hospital.

In July 2021, the Centers for Disease Control and Prevention (CDC) released a report that stated: "An elevated risk for myocarditis among mRNA COVID-19 vaccinees has been observed, particularly in males aged 12–29 years."

The report found, "Myocarditis reporting rates were 40.6 cases per million second doses of mRNA COVID-19 vaccines administered to males aged 12−29 years."

The CDC added, "Myocarditis and pericarditis have rarely been reported. When reported, the cases have especially been in adolescents and young adult males within several days after mRNA COVID-19 vaccination (Pfizer-BioNTech or Moderna)."

In April, an Israeli large-population study of 196,992 unvaccinated adults who were post-COVID-19 infection were "not associated with either myocarditis or pericarditis."

"We did not observe an increased incidence of neither pericarditis nor myocarditis in adult patients recovering from COVID-19 infection," the authors wrote.

Pfizer and BioNTech combination COVID-19 and flu vaccine could be on the horizon



Pfizer and BioNTech have announced the launch of a phase 1 trial for a dual-purpose mRNA-based vaccine to tackle both influenza and COVID-19.

"The vaccine candidate combines Pfizer’s quadrivalent modRNA-based influenza vaccine candidate, qIRV (22/23), which is currently in Phase 3 clinical development, and Pfizer and BioNTech’s authorized Omicron-adapted bivalent COVID-19 BNT162b2 (Original/Omicron BA.4/BA.5) vaccine, each of which is based on BioNTech’s proprietary mRNA platform technology," according to a press release.

\u201cToday we announced a Phase 1 study with @BioNTech_Group of an #mRNA-based combination vaccine candidate for #influenza and #COVID19, aiming to help protect against both diseases at once. Learn more: https://t.co/6TOHyDCT0r\u201d
— Pfizer Inc. (@Pfizer Inc.) 1667473748

"The flexibility and manufacturing speed of the mRNA technology has demonstrated that it is well-suited for other respiratory diseases. Pfizer is deeply proud of our continued work to explore its potential to protect against influenza and COVID-19 in one combination vaccine, which we think could simplify immunization practices against these two respiratory pathogens, potentially leading to better vaccine uptake for both diseases," said Annaliesa Anderson, Ph.D., senior vice president and chief scientific officer of Pfizer's vaccine research and development team.

While the Pfizer-BioNTech COVID-19 vaccine has been heavily hyped by public health officials, Centers for Disease Control and Prevention director Dr. Rochelle Walensky tested positive for COVID-19 last month despite having received an updated vaccine in September. Then, after taking Paxlovid, she tested negative before eventually testing positive again.

Days after the first announcement that Walensky tested positive last month, President Joe Biden — who has previously tested positive for COVID-19 despite having been fully vaccinated and boosted twice — received an updated shot and urged others to follow suit. The White House also posted a cringeworthy video urging people to get vaccinated.

\u201cAvoid a spooky Thanksgiving.\n \nhttps://t.co/5SMDHKKopq.\u201d
— The White House (@The White House) 1666712125

During his experience with COVID-19 earlier this year, Biden also took Paxlovid, tested negative, and then tested positive again.

The CDC claims that the shots "are effective at protecting people from getting seriously ill, being hospitalized, and dying. As with other vaccine-preventable diseases, you are protected best from COVID-19 when you stay up to date with the recommended vaccinations, including recommended boosters."

Pfizer, BioNTech sponsor cringeworthy Marvel comic that promotes COVID-19 vaccination



Pfizer and BioNTech have sponsored a cringeworthy Marvel comic that serves as a vehicle to promote COVID-19 vaccination.

The story opens with a family waiting to get COVID-19 vaccine shots while the Avengers are just blocks away fighting an enemy known as Ultron.

"Ultron keeps coming back--keeps changing and evolving--so the Avengers keep adapting and re-strategizing. And they knock him back again and again!" the grandfather character says.

Later in the story, the grandfather says, "I've seen their pattern so many times before. Ultron evolves. The Avengers gather information and take time to innovate and adapt." He then says that the Avengers "figure out how to fight it, putting together their existing knowledge and research along with the new information they've learned!"

\u201cWhen Ultron wreaks havoc, the Avengers act as the first line of defense. People can help protect themselves by staying up to date with COVID-19 vaccinations. Head to https://t.co/PfNUYTZlkj to get a first look at Pfizer, BioNTech, and Marvel\u2019s comic book!\u201d
— Pfizer Inc. (@Pfizer Inc.) 1664924402

"The Avengers are doing their part to help keep us safe. Now it's time for us to do ours," the grandfather says as the family heads to get their COVID-19 vaccine jabs.

At the conclusion of the comic, most of the family members can be seen with bandaids on their arms because they have received a COVID-19 vaccine shot.

"Everyday heroes don't wear capes!" an ad at the end of the sponsored comic declares. "But they do wear a small bandage on their upper arm after they get their latest COVID-19 vaccination—because everyday heroes are concerned about their health. And they're people who choose to unite with their communities and do their part to help protect against COVID-19."

Quadruple-jabbed Pfizer chairman and CEO Albert Bourla announced in August that he tested positive for COVID-19 — then in September he announced again that he had tested positive, noting in that statement that he had not yet received the new bivalent booster.

Other prominent vaccine promoters including President Joe Biden and National Institute of Allergy and Infectious Diseases director Dr. Anthony Fauci have tested positive despite having been fully vaccinated and twice boosted.

Pfizer and BioNTech seek FDA emergency use authorization for updated COVID-19 vaccine booster



Pfizer and BioNTech have asked the U.S. Food and Drug Administration to green-light emergency use authorization for an updated COVID-19 vaccine booster shot.

According to a press release, the companies are seeking an EUA for "a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older."

"The bivalent vaccine contains mRNA encoding the original SARS-CoV-2 spike protein, which is present in the original Pfizer-BioNTech COVID-19 Vaccine, together with mRNA encoding the spike protein of the Omicron BA.4/BA.5 variant," the press release said. "Pre-clinical data showed a booster dose of Pfizer and BioNTech's Omicron BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against Omicron BA.1, BA.2 and BA.4/BA.5 variants, as well as the original wild-type strain. A clinical study investigating the safety, tolerability and immunogenicity of the Omicron BA.4/BA.5-adapted bivalent vaccine in individuals 12 years of age and older is expected to start this month."

The booster is set to roll out immediately once the green light is given.

"The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech COVID-19 Vaccine, has allowed us to develop, test and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed," Pfizer chairman and CEO Albert Bourla said, according to the release. "Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorized, to help protect individuals and families as we prepare for potential fall and winter surges."

Prominent figures, including Bourla, have tested positive for COVID-19 after having already received four vaccine shots.

"After isolating all week, I am happy to report that I have now tested negative in 2 consecutive tests. Although I was fortunate to only experience mild symptoms that resolved within a few days, I am grateful for the support and well wishes expressed by so many," Bourla tweeted on Friday.

\u201cAfter isolating all week, I am happy to report that I have now tested negative in 2 consecutive tests. Although I was fortunate to only experience mild symptoms that resolved within a few days, I am grateful for the support and well wishes expressed by so many.\u201d
— Albert Bourla (@Albert Bourla) 1660935237

Poland will not take or pay for any more COVID-19 vaccines from Pfizer



Poland has informed the European Commission and the pharmaceutical giant Pfizer that it will no longer accept nor pay for any more COVID-19 vaccines for now, Poland's health minister said Tuesday.

The decision to stop taking vaccine doses will set up a legal battle under a supply contract the European Union has negotiated with vaccine manufacturers.

Poland and other EU member nations have been paying for and receiving vaccine doses under agreements between the European Union and vaccine manufacturers such as Pfizer and Moderna. Pfizer is the chief supplier for Poland, Reuters reported.

Currently, the country has 25 million COVID-19 vaccines in storage and another 67 million to 70 million doses on order, according to the private news channel TVN24. But compared to other European nations, Poland has reported a below-average vaccine uptake. Just 59% of the country's 38 million people have been fully vaccinated, and only 31% have received a booster shot, below the EU average of 72.5% and nearly 53%, respectively.

As such, Poland's health minister said the country has a surplus of vaccine doses and does not intend to pay for any more.

"We asked both the European Commission and the main vaccine producing companies ... to spread these deliveries over 10 years and — most importantly — to pay when we receive vaccines," health minister Adam Niedzielski reportedly told TVN24 in an interview.

"Unfortunately, here we faced complete inflexibility on the part of the producers,” he said. “There was no way that we could seriously change the terms of this contract, and this contract was signed in a crisis situation."

Niedzielski explained that Poland has triggered a clause in its legal agreement with the European Commission and Pfizer to stop taking additional vaccine doses.

"At the end of last week, we used the force majeure clause and informed both the European Commission and the main vaccine producer that we are refusing to take these vaccines at the moment and we are also refusing to pay," he said.

"Indeed, the consequence of this will be a legal conflict, which is already taking place," he added.

According to the health minister, Poland cannot directly terminate the contract with Pfizer because the agreement is between Pfizer and the European Commission.

Pfizer's contract to supply vaccine doses to Poland alone is worth more than 6 billion zlotys ($1.4 billion), with more than 2 billion zlotys spent on vaccines for 2022.

In a comment to Reuters, Pfizer said its contract to supply vaccines to EU member states is with the European Commission.

"Our discussions with Governments and the details of vaccine deliveries are confidential," Pfizer said.

European Commission health spokesman Stefan de Keersmaecker said Tuesday that member states were bound by contractual obligations to continue purchasing vaccines, but that the commission understands Poland's "difficult position."

"We continue to facilitate discussion between the Polish government and the company in order to find a pragmatic solution to this specific situation the country is confronted with," he said.

Niedzielski said that Poland and 10 other EU countries have petitioned the EU to loosen regulations on COVID-19 vaccine contracts to allow for flexibility to spend money on health care for refugees from the war between Russia and Ukraine.

"We, in particular, and I am talking about Poland here, currently have financial pressures related to the influx of refugees, so we also feel that, on the EU scale, we have a certain right to expect special instruments that will give us ... greater flexibility in the contracts," Niedzielski said.

ABCDEF Your Boosters | Guest: Hilary Kennedy | 12/9/21

ABCDEF Your Boosters | Guest: Hilary Kennedy | 12/9/21

FACT CHECK: Does BioNTech CEO Ugur Sahin Refuse To Take The COVID-19 Vaccine?

'We got our shots at the end of January this year'

BREAKING: Pfizer and BioNTech to submit emergency use authorization request for COVID-19 vaccine to FDA

Pfizer and Biotech said in a statement that they hope to see their vaccine be potentially available by mid-to-late December.

COVID-19 vaccine 95% successful—could shortly be available for emergency use

Pfizer and BioNTech have developed and recently tested BNT162b2—a COVID-19 vaccine which has been found to be over 95 percent successful in preventing the virus through multiple trials.

Pfizer reveals groundbreaking development on vaccine development: Astounding 90 percent effectiveness rate



Pfizer and BioNTech have announced on Monday that their first "milestone" COVID-19 vaccine offers 90 percent protection against the novel coronavirus.

The news comes following a preliminary analysis of the groundbreaking vaccine.

The pharmaceutical companies described Monday as a "great day for science and humanity."

What are the details?

Pfizer and BioNTech announced that they plan to apply for emergency approval through the FDA to begin using the vaccine as early as the end of November. The companies believe they will be able to supply at least 50 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021.

According to CNN, Pfizer said that the vaccine provided protection against the deadly virus just seven days after the second dose and 28 days after the initial dose of the vaccine.

The outlet reported, "The Phase 3 trial of the Pfizer vaccine ... has enrolled 43,538 participants since July 27. As of Sunday, 38,955 of the volunteers have received a second dose of the vaccine."

In a news release, Pfizer CEO Dr. Albert Bourla said, "With today's news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks."

"Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine's ability to prevent COVID-19," Bourla added. "We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today's news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis."

Previously, the U.S. Food and Drug Administration said it expected at least 50 percent efficacy from any vaccine against COVID-19.

Following the announcement, Dow futures soared 1,700 points — nearly 6.1 percent.

President Donald Trump reacted to the news on Twitter, writing, "Stock market up big, vaccine coming soon. Report 90% effective. Such great news!"

STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!
— Donald J. Trump (@Donald J. Trump)1604925104.0

In a statement on the new development, president-elect Joe Biden added, "I congratulate the brilliant women and men who helped produce this breakthrough and to give us such cause for hope. At the same time, it is also important to understand that the end of the battle against COVID-19 is still months away. This news follows a previously announced timeline by industry officials that forecast vaccine approval by late November. Even if that is achieved, and some Americans are vaccinated later this year, it will be many more months before there is widespread vaccination in this country."