Nine Covid-19 Vaccine Developers Pledge To Uphold Scientific Integrity

The CEOs of nine companies developing vaccines against Covid-19 on Tuesday pledged to "uphold the integrity of the scientific process" amid concern Donald Trump will pressure regulators to approve a vaccine ahead of the presidential election in November.

"We, the undersigned biopharmaceutical companies, want to make clear our ongoing commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles," said the CEOs.

The statement was signed by AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi.

Specifically, the companies said they would only seek emergency authorisations for vaccines "after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA," the Food and Drug Administration.

Some experts and former officials of this agency worry it has become politicised after it issued emergency use authorizations for two Covid-19 treatments without sufficient proof.

Both hydroxychloroquine, whose authorization was later revoked over safety fears, and blood plasma from recovered Covid-19 patients, were touted by Trump.

Joe Biden, the Democratic candidate for president, has accused Trump of "undermining public confidence" by regularly raising the possibility a vaccine will be ready ahead of the election on November 3.

Stephen Hahn, the head of the FDA, has also guaranteed that only science will decide when a vaccine is ready.

In theory, the FDA has to rely on independent expert committees that oversee clinical trials before they give their green light. The makers themselves must also apply for authorisation.

Among the companies, Moderna and Pfizer are in the most advanced stages of their trials, and the US Centers for Disease Control and Prevention (CDC) has asked states to have distribution networks ready by November 1.

The widely-respected Anthony Fauci, director of the National Institute of Allergies and Infectious Diseases, has said the results of clinical trials aren't expected to be known until the final two months of the year.

"I think it's extremely unlikely but not impossible," that the trials will have results to show before the election, Moncef Slaoui, the scientific head of the White House program tasked with producing and delivering vaccine doses, told NPR.

According to some people in the medical profession speaking out in regards to vaccination: Vaccines concocted the quick way may be effective against the specific virus they have been designed for, however should you catch a mutated form of the same virus it may leave you open to a host of problems some of them severe enough to do you in. And keep in mind that most viruses do mutate. This is just part of the article, you can find the full article by going to Google. Suggest reading it as it is interesting !

Might Flu Shots Increase COVID-19 Pandemic Risk?
Analysis by Dr. Joseph Mercola

Could a “perfect storm” be brewing, ready to be unleashed this fall? If the regular influenza season ends up converging with a resurgence of SARS-CoV-2 outbreaks, or even a new SARS-CoV-3, the results are anyone’s guess at this point. Confounding matters is the possibility that influenza vaccination may increase people’s risk of other viral infections.

In a June 12, 2020, Science editorial, Michael Osterholm, virologist and director of the Center for Infectious Disease Research and Policy at the University of Minnesota in Minneapolis, and Edward Belongia, director of the Center for Clinical Epidemiology and Population Health at the Marshfield Clinic Research Institute in Marshfield, Wisconsin write:1

“There are important differences in the epidemiology of COVID-19 and seasonal influenza, but symptoms overlap … The prospect of a second COVID-19 wave requires planning to ensure optimal delivery of influenza vaccines starting in the early fall …

The optimal timing of influenza vaccination in patients with confirmed COVID-19 is uncertain. There are no clinical studies on the effects of influenza vaccination in patients with COVID-19, but it may be prudent to delay vaccine administration until after the acute illness has resolved …

Will there be a perfect storm of COVID-19 and influenza during the 2020–2021 season? We do not yet know, but we must start preparing in the coming months.”

‘False Claim’ Is Based on Published Science
Osterholm and Belongia stress there is a “false claim that influenza vaccination increases the risk of SARS-CoV-2 infection” promoted by Judy Mikovits and circulating online, and that “Scientists, health care providers, and public health leaders must counter these claims with clear, evidence-based information on the importance of influenza vaccination during the COVID-19 pandemic.”

But this so-called “false claim” is not a rumor pulled out of thin air. As is so often the case, Osterholm and Belongia are actually insulting fellow virologists and researchers when slapping a hoax label on such claims, seeing how there is published research showing that, yes, influenza vaccination appears to worsen outcomes during viral pandemics.

If Osterholm and Belongia wanted to be factual and clear, they should dissect the actual studies using scientific methods and reasoning, and not just dismiss them as made-up internet hoaxes.

The fact that peer-reviewed studies have come to the conclusion that previous flu vaccination seems to increase patients’ risk of contracting more severe pandemic illness at least worthy of consideration and review.

I’m not surprised though, seeing how Osterholm appears to routinely ignore the reality of published science. In a March 10, 2020, interview with Joe Rogan,2 in which the question of SARS-CoV-2’s origin came up, Osterholm stated that “we could not have crafted a virus like this to do what it’s doing; I mean we don’t have the creative imagination or the skill set.”

This simply does not line up with reality. Again, published research shows we clearly have the technology, know-how and “creative imagination” to create SARS-CoV-2.

Flu Vaccine Increased Risk of Pandemic H1N1
So, what is the basis for these claims? Research raising serious questions about flu vaccinations and their impact on pandemic viral illnesses include a 2010 review3,4 in PLOS Medicine, led by Dr. Danuta Skowronski, a Canadian influenza expert with the Centre for Disease Control in British Columbia, which found the seasonal flu vaccine increased people’s risk of getting sick with pandemic H1N1 swine flu and resulted in more serious bouts of illness.

People who received the trivalent influenza vaccine during the 2008-2009 flu season were between 1.4 and 2.5 times more likely to get infected with pandemic H1N1 in the spring and summer of 2009 than those who did not get the seasonal flu vaccine.

In all, five observational studies conducted across several Canadian provinces found identical results. These findings also confirmed preliminary data from Canada and Hong Kong. As Australian infectious disease expert professor Peter Collignon told ABC News at the time:5

“Some interesting data has become available which suggests that if you get immunized with the seasonal vaccine, you get less broad protection than if you get a natural infection …

We may be perversely setting ourselves up that if something really new and nasty comes along, that people who have been vaccinated may in fact be more susceptible compared to getting this natural infection.”

Double-Blind Animal Study Confirmed Results
To double-check the findings, Skowronski and other researchers conducted a study on ferrets. Their findings were presented at the 2012 Interscience Conference on Antimicrobial Agents and Chemotherapy. As reported by MedPage Today:6

“A double-blind, placebo-controlled animal study suggests that vaccination with seasonal influenza vaccine did, in fact, worsen symptoms after subsequent exposure to H1N1 flu … The vaccinated ferrets also accumulated significantly greater lung virus titers — 4.96 plot forming units/ml versus 4.23 pfu/ml ...

‘We did find that the ferret findings were consistent with our earlier human studies,’ Skowronski said, noting that the scientifically stringent experiment used ferrets, considered to be excellent models of human influenza infection …

‘We needed to follow up on those studies from Canada. They were clearly indicating something important about the interaction between seasonal and pandemic viruses,’ she said.

‘First, people attributed the human findings to bias and confounding. That is a common problem with observational studies … Our ferret studies showed that the findings could not be explained away on the basis of confounding.

There may be a direct vaccine effect in which the seasonal vaccine induced some cross-reactive antibodies that recognized pandemic H1N1 virus, but those antibodies were at low levels and were not effective at neutralizing the virus,’ she continued, explaining that instead of killing the new virus it actually may facilitate its entry into the cells.”

Flu Vaccine Increases Risk of Respiratory Infections
Another study,7 published in the Journal of Virology in 2011, found the seasonal flu vaccine weakens children’s immune systems and increases their chances of getting sick from influenza viruses not included in the vaccine.

Further, when blood samples from 27 healthy, unvaccinated children and 14 children who had received an annual flu shot were compared, the former unvaccinated group was found to have naturally built up more antibodies across a wider variety of influenza strains compared to the latter vaccinated group, which is the type of situation Collignon referred to in the quote above.

Then there’s a 2012 study8,9 in the journal Clinical Infectious Diseases, which found that children receiving inactivated influenza vaccines had a 4.4 times higher relative risk of contracting noninfluenza respiratory virus infections in the nine months following their inoculation.

The authors proposed the theory that “Being protected against influenza, trivalent inactivated influenza vaccine recipients may lack temporary nonspecific immunity that protected against other respiratory viruses.”

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