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Pfizer to Seek Emergency Use Authorization for COVID Booster Shots — But CDC, FDA Say Science Is Lacking

By Megan Redshaw | The Defender

Pfizer announced Thursday it will seek Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) in August for the third dose of its COVID-19 vaccine. The drugmaker predicted those who have been fully vaccinated will need a booster shot within six to 12 months of receiving their second dose of the Pfizer vaccine.

But hours later, the U.S. Department of Health and Human Services (HHS) issued a joint statement by the FDA and Centers for Disease and Control and Prevention (CDC) saying, “Americans who have been fully vaccinated do not need a booster shot at this time.”

The statement did not explicitly mention Pfizer but said: “a science-based, rigorous process” headed by the CDC, FDA and the National Institutes of Health would determine when or whether boosters were necessary.

According to the HHS statement:

“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.”

In a statement to CNN Friday, the World Health Organization said:

“We don’t know whether booster vaccines will be needed to maintain protection against COVID-19 until additional data is collected,” adding, “limited data [is] available on how long the protection from current doses lasts, and whether an additional booster dose would be beneficial and for whom.”

Scientists “applauded the statement” from HHS, The Washington Post reported, saying boosters were not imminent and the science isn’t clear on if or when they will be needed.

“My opinion right now … is that current vaccination seems to be large‘ holding,’” said E. John Wherry, an immunologist at the University of Pennsylvania’s Perelman School of Medicine. “But the companies seem to suggest their continued follow-up of their trial patients shows concerning levels of the waning of immunity. Not much of these data from the companies are publicly available yet. I agree we need as much independent data and assessment as possible on this topic.”

John P. Moore, professor of microbiology and immunology at Weill Cornell Medicine, said:

“No one is saying we’ll never need a booster, but to say we need it now and give the public the impression the vaccines are failing and something needs to be done as a matter of urgency. … The time isn’t now. The decisions that are going to be made will be made by federal agencies.”

The HHS statement followed recommendations made June 23 by the CDC’s Advisory Committee on Immunization and Practices (ACIP). Members of the ACIP COVID-19 working group said they would recommend booster shots only if there were a demonstrated decline in efficacy — not just a waning antibody response.

Boosters may be recommended if there’s a variant that’s able to evade the vaccines, according to slides presented by Dr. Sara Oliver, a medical epidemiologist with the CDC’s National Center for Immunization and Respiratory Diseases.

Dr. Sharon Frey, ACIP member and clinical director of the Center for Vaccine Development at Saint Louis University Medical School, said:

“I would have to agree with the interpretation of the working group in the sense that there’s no data to support recommendations to support boosters at this time. There’s no evidence against declining protection at this time.”

Pfizer CEO insists boosters are needed

Pfizer has been working on two different booster strategies it anticipates could carry sales beyond the immediate pandemic need: a third 30 mg dose of its current vaccines and an updated vaccine that targets the South African variant.

All U.S. pharmaceutical companies involved in making COVID vaccines are working on formulating and testing booster shots to prepare for the possibility, The Washington Post reported.

Pfizer argued that as antibody blood concentration wanes, boosters will be required to ensure the broad population can’t carry the virus. This would quench the epidemic faster, the company said.

Pfizer said its vaccine’s effectiveness had eroded, citing two lines of evidence outside scientists have not seen in detail. This included an Israeli government analysis that showed reduced efficacy with Pfizer’s vaccine and the Delta variant and data from Pfizer’s continued follow-up of people who were vaccinated last summer.

“While protection against severe disease remained high across the full six months, the observed decline in efficacy against symptomatic disease over time, and the continued emergence of variants, are key factors driving our belief that a booster dose will likely be necessary to maintain highest levels of protection,” Pfizer said in a statement.

Pfizer said it would submit data to regulators within weeks showing the third dose of its vaccine at six months caused antibody levels to shoot up to five to 10 times higher than the original two-dose regimen. Moderna announced similar data in May.

Pfizer motivated by profit margins

Less than 24 hours after Pfizer announced plans to seek emergency use authorization of a third dose, the drugmaker’s stock was up 1.6%.

Pfizer CEO Albert Bourla has said for months a booster would likely be needed within a year of the initial two-dose inoculation — followed by annual vaccinations, even as public health officials and academic scientists said it wasn’t clear yet when a booster would be needed.

Booster shots for COVID are expected to serve as a key revenue driver in the years to come for Pfizer and its primary rival in the U.S., Moderna. Pfizer in May projected global sales of its COVID vaccine to reach $26 billion in 2021.

The company has also been frank that it’s current pricing — $19.50 per dose in the U.S. — is temporary. On an earnings call in February, Frank A. D’Amelio, Pfizer’s executive vice president of global supply, assured investors the company sees the vaccine market evolving as the pandemic wanes, and will likely be able to charge more per dose than it was getting under pandemic supply deals.

D’Amelio said a more typical price for vaccination was $150 or $175 per dose.

“Now, let’s go beyond a pandemic-pricing environment, the environment we’re currently in. Obviously, we’re going to get more on price,” D’Amelio said. “So clearly, there’s a significant opportunity for those margins to improve once we get beyond the pandemic environment that we’re in.”

Pfizer said it would begin testing a booster shot specifically programmed to combat the Delta variant in August, reaffirming concerns by scientists who predicted in April that pharmaceutical companies like Pfizer, would create a vaccine treadmill with continuous booster shots targeted at emerging variants.




CDC Experts Disagree With Pfizer on COVID Boosters, Threatening Pharma Giant’s Billion Dollar Revenue Stream

By Megan Redshaw | The Defender

As Pfizer makes plans to keep its billion-dollar revenue stream going — by assuring investors yearly COVID booster doses will be needed long after the pandemic ends — a group of scientists from the Centers for Disease Control and Prevention (CDC) said there isn’t enough data to recommend COVID booster shots to the general population.

The COVID-19 working group of the CDC’s Advisory Committee on Immunization Practices (ACIP) said on June 23, they would only recommend booster shots if there’s a demonstrated decline in efficacy –– not just a waning antibody response.

Boosters may also be recommended if there’s a variant that’s able to evade the vaccines, according to slides presented by Sara Oliver, M.D., a medical epidemiologist with CDC’s National Center for Immunization and Respiratory Diseases.

Currently, there’s no evidence to suggest a booster is needed, the experts said. Boosters may be appropriate for special risk groups in the future, including elderly people and transplant recipients. To be sure, the nation’s top public health officials said they would continue to monitor the situation.

“I would have to agree with the interpretation of the working group in the sense that there’s no data to support recommendations to support boosters at this time,” said Dr. Sharon Frey, member of the ACIP and clinical director of the Center for Vaccine Development at Saint Louis University Medical School. “There’s no evidence against declining protection at this time.”

Dr. Grace Lee, chair of the ACIP safety panel and professor of pediatrics at Stanford University School of Medicine, said she would like to see more evidence of breakthrough cases before recommending a booster shot.

“I would want greater certainty on the safety data if we’re talking about boosting before it’s clear what the risk data will look like,” Lee said. “If we’re seeing severe breakthrough cases then I think the decision-making moves forward even if there’s uncertainty with the safety data.”

CDC expert recommendations threaten Pfizer profits

Booster shots for COVID are expected to serve as a key revenue driver in the years to come for Pfizer and Moderna. Pfizer executives have assured investors the company sees the vaccine market evolving as the pandemic wanes, and will likely be able to charge more per dose than it was getting under pandemic supply deals.

Pfizer has been working on two different booster strategies it anticipates could carry sales beyond the immediate pandemic need — a third 30 mg dose of its current vaccines and an updated vaccine that targets the South African variant, Fierce Pharma reported.

No one is completely sure when a booster will be needed, but it’s possible that some of those who were vaccinated early on may need an extra jab as early as September, or roughly 8 to 12 months after their initial regimen, CEO Albert Bourla told Axios in May.

Pfizer has argued that boosters would be required “as antibody blood concentration wanes to ensure the broad population can’t carry the virus and thus quench the epidemic faster,” the Bernstein analysts, led by Ronny Gal, wrote to clients. That’s not the industry’s standard, and it’s also not what the CDC’s ACIP suggested at its meeting on June 23, analysts wrote.

A Pfizer spokesperson told Fierce Pharma the company’s “current thinking is that until we see a reduction in SARS-CoV-2 circulation and COVID-19 disease, we think it is possible that a third dose, a boost of our vaccine, could be needed to help provide protection against COVID-19,” subject to regulatory approval.

Pfizer’s COVID vaccine is already the second-highest revenue-generating drug in the world, with a projected revenue forecast of $26 billion in 2021 alone — a 70% increase in its originally projected profits.

The forecast is based on contracts to deliver 1.6 billion vaccine doses this year. The company expects to sign more deals for this year and is in supply talks with several countries for 2022 and beyond.

During an investor conference in March, Pfizer’s CFO Frank D’Amelio said the company sees “significant opportunity” for its COVID vaccine once the market shifts from a “pandemic situation to an endemic situation.”

At that point “factors like efficacy, booster ability, the clinical utility will basically become very important, and we view that as, quite frankly, a significant opportunity for our vaccine from a demand perspective, from a pricing perspective, given the clinical profile of our vaccine,” D’Amelio told the analyst.

During the Barclays’ Global Health Conference in March, D’Amelio said the company doesn’t see this as a one-time event, but “as something that’s going to continue for the foreseeable future.”

Bourla said a third dose of the company’s COVID vaccine was “likely” to be needed within a year of the initial two-dose inoculation — followed by annual vaccinations.

“Every year, you need to go to get your flu vaccine,” Bourla said. “It’s going to be the same with COVID. In a year, you will have to go and get your annual shot for COVID to be protected.”

Like Pfizer, Moderna’s chief commercial officer, Corinne M. Le Goff said during a call with investors in April that Americans could start getting booster shots of its vaccine later this year to protect against COVID variants.

“It is likely that the countries that have already achieved high vaccine coverage are going to be ready to shift their focus to boosters in 2022, and possibly even starting at the end of this year,” Le Goff said.

Johnson & Johnson (J&J) has said its vaccine will probably need to be given annually, despite being heavily marketed to consumers as a one-dose vaccine.

As The Defender reported in May, pharmaceutical companies and their CEOs have made billions from COVID vaccines, massive compensation packages, and questionable stock sales while reassuring investors that plans were underway for boosters and annual shots.




46 Nursing Home Residents in Spain Die Within 1 Month of Getting Pfizer COVID Vaccine

By Celeste McGovern | The Defender

Forty-six nursing home residents who had received their first dose of Pfizer-BioNTech’s fast-tracked vaccination against COVID-19 at the beginning of January had died by the end of the month, Spanish media have reported.

Staff first reported a coronavirus outbreak at Nuestra Señora del Rosario (Our Lady of the Rosary), a nursing home in the province of Cadiz, Andalusia in Spain on Jan.12, in the wake of a vaccine distribution campaign.

The Ministry of Housing and Families intervened in the private facility which houses up to 145 residents and where local media reported on Feb. 4 that a further 28 of 94 residents as well as 12 staff members had tested positive for COVID-19.

At another nursing home in the same southwestern Spanish province, in Novo Sancti Petri, in Chiclani, 22 elderly residents died and 103 were infected following a vaccination campaign.

Similar outbreaks and death clusters following vaccination have been reported across the globe, including:

  • 10 deaths in German palliative care patients within hours to four days of COVID-19 vaccination were deemed a “coincidence.”
  • 22 of 72 residents of a nursing home in Basingstoke, England have died following vaccination.
  • 24 seniors at a nursing home in Syracuse, NY were reported to have died from COVID-19 as of Jan. 9 despite having been vaccinated beginning Dec. 22.
  • 10 cases of COVID-19 were reported on Jan. 28 among seniors who had received both doses of Pfizer’s vaccine at one care home in Stockholm Sweden. The residents were vaccinated on Dec. 27 and again on Jan.19.
  • The COVID-19 death toll in the small British enclave of Gibraltar numbered 16 before it launched its Pfizer vaccination campaign on Jan. 10 and then shot up to 53 deaths 10 days later and to 70 seven days after that. According to a Reuters report, the Gibraltar Health Authority declared there was “no evidence at all of any causal link” between 6 of the deaths that were investigated and Pfizer’s vaccine, despite the individuals having tested negative for COVID before vaccination, but positive “in the days immediately after.”
  • 4,500 COVID-19 cases in Israel occurred in patients after they had received one dose of Pfizer’s vaccine and 375 of those vaccinated patients required hospitalization, Israeli news media reported on Jan.12.
  • Seven adults living in a care home in Saskatoon tested positive for coronavirus a week after residents were vaccinated at the Sherbrooke Community Centre, the CBC reported. There were no positive cases at the time of vaccination.
  • Seven residents at a Montreal long-term care facility tested positive for COVID- within 28 days of being vaccinated with Pfizer’s vaccine, prompting the province of Quebec to delay the second Pfizer dose.
  • Abercorn Care Home in Scotland, which began COVID-19 vaccinations on Dec. 14 was home to an outbreak of the virus by Jan. 10 and the National Health Service for the region refused to comment on whether vaccinated residents were ill. A care home staff group founder told the Scottish Daily Record: “We have had members of our group whose parents have had the vaccine and then two weeks later have tested positive for coronavirus.”
  • All of the residents at a home in Inverness, Scotland were vaccinated against COVID early in January, but 17 became infected with the virus after the first dose.

The UK Medical Freedom Alliance — a group of doctors, scientists, lawyers, and other professionals who advocate for informed consent in the UK — published an urgent open letter to Nadhim Zahawi, Minister for COVID-19 vaccine deployment; Matt Hancock, the Secretary of State for Health and Social Care; and two vaccine oversight agencies calling for an immediate audit of the deaths following vaccination in the UK.

The group refers to graphs showing a surge in care home deaths and cites data from the Office for National Statistics that residents’ deaths tripled in the two weeks between January 8- 22 at a time when there was a massive increase in the rate of vaccinations in care homes.

Similar graphs for Israel, Ireland, Bahrain, and Jordan show a similar correlation.

The UK Medical Freedom Alliance points to the “statistically insignificant” safety data on elderly people in COVID, who they say were “under-represented” in vaccine clinical trials.

“We postulated that there may be increased vaccine side-effects in this group, which would only become apparent when many thousands of them had received vaccinations,” the letter states.

The World Health Organization’s Strategic Advisory Group of Experts updated its recommendations for Moderna’s vaccine administration on Jan. 26 stating that while vaccination is recommended for older persons due to the risks of COVID infection, “very frail older persons with an anticipated life expectancy of fewer than 3 months” should not be automatically vaccinated but should be “individually assessed.”

Originally published by Life Site News.

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