British Medical Journal Contested FDA for “Political Decision” on Full Approval of Pfizer Vaccine without Public Discussion of Data
di Fabio Giuseppe Carlo Carisio
To extinguish a dangerous controversy in the bud, it is always better to pass from words to deeds. Thus, on Monday, 23 the Food and Drug Administration granted full and definitive approval to the Comirnaty gene therapy against Covid produced by the American multinational Pfizer together with the German BioNtech, previously allowed for use. commercial only by virtue of the emergency authorization of 11 December 2020.
This happened just as the British Medical Journal (BMJ) had raised a peremptory challenge to the ways in which the FDA leaders would have approved the vaccine, implementing what was announced – but in fact ordered – by American President Joseph Biden a month ago.
The American drug regulatory body, in fact, had announced a few days ago, among the amazement of many experts, that it would not convene the VRBPAC (Vaccines and Related Biological Products Advisory Committee) created within the FDA itself precisely for share and examine in a public discussion, including with independent experts, the pharmacovigilance data on the effects of anti-Covid sera provided by Pfizer (or possibly from other platforms).
This has aroused the vibrant protests of some members of the same Committee, as reported below, inducing the British specialist magazine BMJ to speak of a “political” decision. As it actually appears self-evident …
«The Food and Drug Administration granted full approval to Pfizer-BioNTech’s two-dose vaccine Monday for people ages 16 and up, making it the first Covid-19 vaccine to pass this final regulatory hurdle» wrote NBC News.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the Covid-19 pandemic,” acting FDA Commissioner Dr. Janet Woodcock said in a statement. “While millions of people have already safely received Covid-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
According to FDA website, since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.
«The first EUA, issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals. To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population» highlighted Food and Drug Administration minimizing side effects.
Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.
Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease. More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.
Mandatory vaccines on the horizon in the US and the EU
«Full approval may help persuade some vaccine-hesitant people to get vaccinated. A Kaiser Family Foundation survey from June found that 3 in 10 unvaccinated adults would be more likely to get the shots if a vaccine were fully approved» added NBC.
«The FDA’s decision may also pave the way for more vaccination mandates: Many businesses were waiting for full approval before they required employees to be vaccinated. Public health experts praised the decision» noted the network, which in recent days had given space to Biden’s announcement in which he had confirmed the intention of the Secretary of the Defense Department, Lloyd Austin, to make the vaccine mandatory for all troops of the US armed forces.
“Full approval could not come at a more important time, as the highly contagious delta variant continues to drive up caseloads and deaths across the U.S.,” Dr. Richard Besser said in a statement. Besser is the Robert Wood Johnson Foundation president and CEO and a former acting director of the Centers for Disease Control and Prevention. “I am hopeful that full approval will address any remaining concerns and will move many people to a ‘yes’ on vaccination.”
The message that comes from the US, in light of the conflicts of interest among Biden, Big Pharma and Bill Gates that Gospa News has been denouncing for months, can be summarized in one sentence “The vaccine is Cosa Nostra, no one can question it”.
The approval from the FDA is also projected on the European Union and in Italy where in all probability the EMA first and then AIFA will imitate the example of the Americans. This would make it easier to impose a mandatory vaccine for the entire population, as already hypothesized by the Undersecretary of Health Pierpaolo Sileri, if Italy does not reach the threshold of 80% of vaccinated by September.
The global immunization plan orchestrated by that “New World Order”, who was prophesied by the former CIA deputy director of the Obama-Biden administration, Avril Haines (now promoted to Director of National Intelligence of all the US Community) and deemed essential to combat the pandemic, is therefore increasingly taking shape.
None of the politicians and doctors involved in this diabolical project are interested in the fact that multiple scientific studies have highlighted the risks of contagion and death from Covid among the vaccinated. Perhaps because, as reported in a public meeting by the psychiatrist and former Italian parliamentarian Alessandro Meluzzi, “false vaccines”, or harmless physiological solutions, are used in the “upper echelons”.
Final Ok to Pfizer Vaccine without Public Data Discussion
Posted on August, 23 before FDA full approval news
After the announced stop to PCR Swabs with the withdrawal of the authorization requested from the Food and Drug Administration by the CDC (Centers of Disesease Control and Prevention) for the unreliability of the tests, that continue to be used all over the world to detect infections and decide on health measures (mandatory vaccines, Green Pass, lockdown, etc.), now the controversy breaks out about the fact that the FDA itself, as announced by US President Joe Biden, is “ready to grant full approval to the Pfizer vaccine without public discussion of the data”.
The data refer to the monitoring of some vaccinates followed by the Comirnaty gene therapy company (made with the messenger RNA active ingredient of the German company BioNtech) which, however, could also have been compared with those deriving from passive pharmacovigilance reports.
These, as we know, have highlighted hundreds of thousands of suspected adverse reactions, in thousands of cases even fatal, both on the American VAERS platform (monitored by the CDC) and on the EudraVigilance platform of the European Medicines Agency.
The contestation of the method, absolutely burdensome also on the merits, comes from the United Kingdom and more precisely from one of the most authoritative specialized journals in the sector, the British Medical Journal, which has collected the complaints of independent American observers who have been denied to participate in the discussion on the final approval of the Comirnaty, as the Advisory Committee has not been convened for a public analysis of the data.
“These public meetings are imperative in building trust and confidence especially when the vaccines came to market at lightning speed under emergency use authorisation,” said Kim Witczak, a drug safety advocate who serves as a consumer representative on the FDA’s Psychopharmacologic Drugs Advisory Committee.
“It is already concerning that full approval is being based on 6 months’ worth of data despite the clinical trials designed for two years,” she said. “There is no control group after Pfizer offered the product to placebo participants before the trials were completed”.
“It’s obvious that the FDA has no intention of hearing anyone else’s opinion. But if you make decisions behind closed doors it can feed into hesitancy. It’s important to have a public discussion about what kind of data are there and what the limitations are. As we think about risk versus benefit, we need to know” told BMJ Diana Zuckerman, president of the National Center for Health Research, who has also spoken at recent VRBPAC meetings.
“They know they can’t win this argument on the science and that’s why they had to abolish the public process and independent oversight,” said Children’s Health Defense Chairman Robert F. Kennedy Jr. “They believe themselves so powerful now that they are stripping off all pretenses that this is about public health, and are baldly revealing the corruption.”
Kennedy told The Defender: “This is a sinister scheme for mandating a badly flawed vaccine that has already made history with record deaths and injuries, that neither prevents disease nor transmission, and does not improve mortality. Pfizer’s most recent six-month data show that while the jab prevents some COVID deaths, it causes more heart attacks yielding a net loss of life.”
«But with the US government indicating this week that it plans to start making booster shots widely available next month, experts said the decision not to meet to discuss the data was politically driven» further wrote British Medical Journal.
A very heavy accusation given that, as stigmatized several times by Gospa News, President Biden was financed in the election campaign by the American Big Pharma Pfizer, controlled by the London-based GSK and therefore also by Bill Gates.
Gates is the historic megadonor of the American Democratic Party and the creator of the global immunization plan with Barack Obama, but also financier of those researches on chimeric superviruses of the Wuhan Institute of Virology and of the University of Carolina on which intelligence experts and virology that support the artificial origin of the SARS-Cov-2 virus, that of the current pandemic, and even its 2003 SARS predecessor.
It should not be forgotten that Biden himself has financed the COVAX anti-Covid plan of the World Health Organization, aimed at poor countries, managed by the UN Gavi di Gates and administered by a former manager of the vaccine giant GlaxoSmithKline which holds 70% of Pfizer’s commercial network, in a macroscopic and shameful conflict of interest that culminated in a strategy already announced.
Much of that money from the US administration, in fact, will be used to buy half a billion doses of the Comirnaty vaccine, thus enriching Pfizer-Gsk investors, among which, in addition to Gates himself, the staunch Zionists founders of the funds American investment BlacRock (Larry Fink) and Elliott (Paul Singer) stand out. (below the full article of the British Medical Journal).
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no reproduction without authorization
Covid-19: FDA set to grant full approval
to Pfizer vaccine without public discussion of data
Published by British Medical Journal on August, 20,2021
Transparency advocates have criticised the US Food and Drug Administration’s (FDA) decision not to hold a formal advisory committee meeting to discuss Pfizer’s application for full approval of its covid-19 vaccine.
Last year the FDA said it was “committed to use an advisory committee composed of independent experts to ensure deliberations about authorisation or licensure are transparent for the public.”1 But in a statement, the FDA told The BMJ that it did not believe a meeting was necessary ahead of the expected granting of full approval.
“The FDA has held numerous meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) related to covid-19 vaccines, including a 22 October 2020 meeting to discuss, in general, the development, authorisation, and licensure of covid-19 vaccines,” an FDA spokesperson said.
“The FDA also has held meetings of the VRBPAC on all three covid-19 vaccines authorised for emergency use and does not believe a meeting is needed related to this biologics license application.”
The spokesperson added, “The Pfizer BioNTech covid-19 vaccine was discussed at the VRBPAC meeting on 10 December 2020.3 If the agency had any questions or concerns that required input from the advisory committee members we would have scheduled a meeting to discuss.”
The vaccine has already been rolled out to millions of Americans through an emergency use authorisation. Companies typically apply for full approval after a longer period has elapsed so that more data are available for review.
But with the US government indicating this week that it plans to start making booster shots widely available next month, experts said the decision not to meet to discuss the data was politically driven.
Kim Witczak, a drug safety advocate who serves as a consumer representative on the FDA’s Psychopharmacologic Drugs Advisory Committee, said the decision removed an important mechanism for scrutinising the data.
“These public meetings are imperative in building trust and confidence especially when the vaccines came to market at lightning speed under emergency use authorisation,” she said. “The public deserves a transparent process, especially as the call for boosters and mandates are rapidly increasing. These meetings offer a platform where questions can be raised, problems tackled, and data scrutinised in advance of an approval.”
Witczak is one of the more than 30 signatories of a citizen petition5 calling on the FDA to refrain from fully approving any covid-19 vaccine this year to gather more data. She warned that without a meeting “we have no idea what the data looks like.”
“It is already concerning that full approval is being based on 6 months’ worth of data despite the clinical trials designed for two years,” she said. “There is no control group after Pfizer offered the product to placebo participants before the trials were completed.
“Full approval of covid-19 vaccines must be done in an open public forum for all to see. It could set a precedent of lowered standards for future vaccine approvals.”
Diana Zuckerman, president of the National Center for Health Research, who has also spoken at recent VRBPAC meetings, told The BMJ, “It’s obvious that the FDA has no intention of hearing anyone else’s opinion. But if you make decisions behind closed doors it can feed into hesitancy. It’s important to have a public discussion about what kind of data are there and what the limitations are. As we think about risk versus benefit, we need to know.”
Joshua Sharfstein, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health and former FDA deputy commissioner during the Obama administration, said that advisory committee meetings were more than just a way of receiving scientific input from outside experts. “It’s also an opportunity to educate the public about the important work that the FDA has done reviewing an enormous amount of data about a product,” he told The BMJ. “It’s a chance for questions to be asked and answered, building public confidence.
“If there are no advisory committee meetings prior to licensure, the FDA should consider taking extra steps to explain the basis of its decisions to the public.”
On 18 August, before the news that the FDA would not be holding a formal committee meeting, the president of the Infectious Diseases Society of America Barbara Alexander praised the impact of the VRBPAC meetings as “a critical and necessary part” of the process for assessing whether to give booster doses.