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Covid-19: FDA Set to Grant Full Approval to Pfizer Vaccine Without Public Discussion of Data

By Gareth Iacobucci

British Medical Journal

BMJ 2021; 374 doi: https://doi.org/10.1136/bmj.n2086 (Published 20 August 2021) Cite this as: BMJ 2021;374:n2086

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 20202 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.

Data scrutiny

Kim Witczak, a drug safety advocate who serves as a consumer representative on the FDA’s Psychopharmacologic Drugs Advisory Committee,4 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.”

Public discussion

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.6

[…]

Via https://www.bmj.com/content/374/bmj.n2086

Revolutionary Association of Women of Afghanistan (RAWA) Responds to Taliban Takeover

By Afghan Women’s Mission

Afghan Women’s Mission has been in touch with RAWA to address their needs at this urgent time. In this brief Q&A with AWM Co-Director Sonali Kolhatkar, RAWA explains the unfolding situation on the ground as they see it. Click HERE to donate to RAWA now.

Sonali Kolhatkar: For years RAWA spoke out against the U.S. occupation and now that it has ended, the Taliban are back. Could President Biden have withdrawn U.S. forces in a manner that would have left Afghanistan in a safer situation than currently? Could he have done more to ensure the Taliban were not so quickly able to take over?

RAWA: In the past 20 years, one of our demands was an end to the US/NATO occupation and even better if they take their Islamic fundamentalists and technocrats with them and let our people decide their own fate. This occupation only resulted in bloodshed, destruction and chaos. They turned our country into the most corrupt, insecure, drug-mafia and dangerous place especially for women.

From the very beginning we could predict such an outcome. On the first days of the US occupation of Afghanistan, RAWA declared on October 11, 2001:

“The continuation of US attacks and the increase in the number of innocent civilian victims not only gives an excuse to the Taliban, but also will cause the empowerment of the fundamentalist forces in the region and even in the world.”

The main reason we were against this occupation was their backing of terrorism under the nice banner of “war on terror”. From the very first days when the Northern Alliance looters and killers were installed back into power in 2002 to the last so-called peace talks, deals and agreements in Doha and release of 5000 terrorists from prisons in 2020/21, it was very obvious that even the withdrawal won’t have a good end.

The Pentagon proves that none of the theory invasion or meddling ended up in safe condition. All imperialist powers invade countries for their own strategic, political and financial interests but through lies and the powerful corporate media try to hide their real motive and agenda.

It is a joke to say values like “women’s rights”, “democracy”, “nation-building” etc. were part of the US/NATO aims in Afghanistan! US was in Afghanistan to turn region into instability and terrorism to encircling the rival powers especially China and Russia and undermining their economies via regional wars. But of course the US government did not want such a disastrous, disgraceful and embarrassing exit that left behind such a commotion that they were forced to send troops again in 48 hours to control the airport and safely evacuate its diplomats and staff.

We believe the US left Afghanistan out of its own weaknesses not defeated by its creatures (Taliban). There are two significant reasons for this withdrawal.

The main reason is the multifold internal crisis in the US. The signs of the US system decline was seen in the weak response to Covid-19 pandemic, attack on Capitol Hill and the great protests of the US public in the past few years. The policy-makers were forced to withdraw troops to focus on internal burning issues.

The second reason is that the Afghan war was an exceptionally expensive war whose cost has gone into trillions, all taken from taxpayer money. This put such a heavy dent on the US financially that it had to leave Afghanistan.

The war-mongering policies prove that their aim was never to make Afghanistan safer, let alone now when they are leaving. Furthermore, they also knew that the withdrawal would be chaotic yet they still went ahead and did it. Now Afghanistan is in the limelight again due to the Taliban being in power but this has been the situation for the past 20 years and everyday hundreds of our people were killed and our country destroyed, it just was rarely reported in the media.

Sonali Kolhatkar: The Taliban leadership are saying they will respect women’s rights as long as it complies with Islamic law. Some Western media are painting this in a positive light. Didn’t the Taliban say the same thing 20 years ago? Do you think there is any change in their attitude toward human rights and women’s rights?

RAWA: The corporate media is only trying to put salt on our devastated people’s wounds; they should be ashamed of themselves the way they try to sugarcoat brutal Taliban. The Taliban spokesperson declared that there is no difference between their ideology of 1996 and today. And what they say about women’s rights is the exact phrases used during their previous dark rule: implementing Sharia law.

[…]

https://www.afghanwomensmission.org/2021/08/rawa-responds-to-the-taliban-takeover/

Coronavirus cases spike in highly vaccinated Israel but drop in unvaccinated Palestine

Dr Eddy Betterman

The Middle Eastern states of Israel and Palestine show contrasting figures in both vaccination rates and case counts amid the ongoing pandemic. Israel recently saw a massive spike in Wuhan coronavirus (COVID-19) cases despite three-fifths of its population being vaccinated. Meanwhile, Palestine saw its COVID-19 cases drop even though more than 90 percent of its population remains unvaccinated.

Naturopathic doctor Suneil Jain pointed out the stark contrast in a tweet. His post said: “Palestine: 8.2 percent of the population is fully vaccinated. Israel: 62 percent of the population is fully vaccinated. Guess which one is doing better?”

Jain pointed to figures from the website OurWorldInData.org to support his tweet. He compared the vaccination rates and the number of COVID-19 cases in both countries and found that the former was directly proportional to the latter. While Israel suffers from high case counts despite the majority of its citizens being vaccinated, Palestine, with many remaining unvaccinated, has seen a steady drop.

As of Aug. 10, more than half of Israel’s population have been fully vaccinated, while only 8.2 percent of Palestinians have received two doses of coronavirus vaccines. Palestine has only administered around 1 million COVID-19 vaccine doses, a small number compared to the more than 10 million doses administered by Israel.

Furthermore, figures from OurWorldInData.org show that the daily number of new COVID-19 cases in Israel has surpassed the 3,500 mark. Meanwhile, daily new COVID-19 cases in Palestine never went beyond 500. These figures suggest that COVID-19 vaccines are not only ineffective, but they could also be responsible for the new wave of COVID-19 infections.

According to the COVID-19 Vaccine Tracker, Israel procured and approved both the Pfizer/BioNTech and Moderna mRNA vaccines for use. On the other hand, Palestine relied on donated vaccines for its vaccination program. The country received a total of 37,440 doses of the Pfizer/BioNTech vaccine and 24,000 doses of the AstraZeneca vaccine through the World Health Organization‘s COVAX initiative. Palestine also received doses of the Russian-made vaccine, Sputnik V, according to a BBC report.

Israel relied too much on the Pfizer/BioNTech vaccine

Israel used the two-dose Pfizer/BioNTech COVID-19 vaccine on a huge percentage of its population, alongside the two-dose Moderna vaccine. More than 5.4 million Israelis received the Pfizer/BioNTech shot in the country’s widely praised mass inoculation program. However, examinations done by Israeli medical experts reveal that Pfizer’s vaccine may have caused more harm than good.

Back in April 2021, researchers from Tel Aviv University and Israeli healthcare provider Clalit Health Services reported that the Pfizer/BioNTech vaccine increased the risk of people catching COVID-19 variants. They found that Israelis who completed the vaccine’s two-dose schedule were eight times more likely to get infected with the South African B1351 strain. Meanwhile, those who received one dose of the Pfizer/BioNTech shot were at higher risk of catching the British B117 strain.

“We found a disproportionately higher rate of the South African variant among people vaccinated with a second dose, compared to the unvaccinated group. Based on patterns in the general population, we would have expected just one case of the [B1351] variant – but we saw eight,” the study’s lead researcher, Dr. Adi Stern, said. (Related: Study finds Pfizer coronavirus vaccine puts people at HIGHER risk of covid “variants”.)

Months later, the Israeli Ministry of Health (MOH) revealed that the Pfizer/BioNTech vaccine was only 39 percent effective against the B16172 delta variant. The ministry noted this finding in its July 22 report, which included COVID-19 cases recorded between June 20 and July 17. This corresponded with the time of the more infectious variant’s spread in Israel. (Related: Israel faces new coronavirus outbreak even though its citizens already got vaccines.)

The MOH’s report also noted the waning effectiveness of the Pfizer/BioNTech vaccine against COVID-19 transmission. People vaccinated in March and April 2021 had more than 50 percent protection against the COVID-19 virus, while those inoculated in February 2021 only had 44 percent. Israelis inoculated at the start of the year saw their vaccine-induced protection levels drop to a measly 16 percent.

[…]

Via https://dreddymd.com/2021/08/22/coronavirus-cases-spike-in-highly-vaccinated-israel-but-drop-in-unvaccinated-palestine/

Denmark abolishes all Corona measures

Free West Media

Danish parliament recently decided in Copenhagen that all Corona measures should be ended from October 1. There will therefore no longer be a mask requirement and the test regime will be abolished. The Danes will then no longer have to provide evidence of whether they are vaccinated or unvaccinated, or whether they have tested positive or negative.

Copenhagen: All Corona measures are being lifted in view of the increasing incidence figures in Denmark, reported RT Deutsch. Since the beginning of July this value has risen from 31 to 107,2 (as of August 8). At the same time, the upper limits of this Corona indicator has increased significantly.

At the same time, the incidence limits are increased significantly: In communities from 300 to 500 infected people within seven days, in the districts from 500 to 1000. However, the prerequisite is that an increasing number of Covid-19 patients does not overload the health care system.

Denmark’s SSI infectious diseases agency said it no longer relied on vaccination to achieve herd immunity in the country. Tyra Grove Krause, the SSI’s acting academic director, said a new wave of infections were expected after people return to work and school at the end of this summer, but it should not be cause for alarm. “It will be more reminiscent of the flu,” Krause said.

Overall, the current vaccination rate is just under 58,4 percent of fully vaccinated people in Denmark. In Germany, this value is only slightly lower at 54,5 percent (as of August 8) but vaccine advocates have been persistent in their fear-mongering and pressure on the unvaccinated.

Tyrolean lawyer Dr. Renate Holzeisen, meanwhile strongly recommended that all employers refrain from vaccination pressure or compulsory vaccination, because most of them were “obviously not even aware of the far-reaching legal consequences associated with it”.

The fact that the so-called Covid-19 vaccines, according to the official approval documents of the EMA and the European Commission were not developed and approved for the prevention of infection with the SARS-COV-2 virus, but solely to prevent a more severe course of the disease, were conditionally approved for this reason alone, Holzeisen underscored.

The official approval documents therefore show that these substances cannot interrupt the chain of infection because the people treated with them can become infected and thus be infectious. Practice also proves that people who are completely “vaccinated” become infected with the virus and even have the same viral load as “unvaccinated people” as the CDC, among others, has admitted. It is therefore clear that any Covid-19 “compulsory vaccination” actually lacks any justification.

All pressure, including moral pressure (alleged act of solidarity with one’s neighbor) is therefore illegal in terms of criminal and liability law based on the official approval documents.

“As a lawyer advising on corporate law, I strongly recommend that every employer stay away from Covid-19 vaccination pressure or compulsory vaccination, because most of them are obviously not even aware of the far-reaching legal consequences associated with it,” she said.

Via https://freewestmedia.com/2021/08/09/denmark-abolishes-all-corona-measures/

Scientists Blast ‘Rash’ Push for Boosters, Citing ‘Weak Evidence’ to Support Third Shot

By  Megan Redshaw

Scientists opposed to offering booster shots to all Americans said data provided by federal health officials wasn’t compelling enough to support the recommendation — some argued boosters could lead to more vaccine-resistant variants.

Scientists criticized the Biden administration’s push to distribute COVID vaccine booster shots in the U.S. next month, saying data provided by federal health officials this week wasn’t compelling enough to recommend a third dose for most Americans.

According to Kaiser Health News, some scientists say the announcement is “rash and based on weak evidence” — and they worry it could undercut confidence in vaccines, with no clear benefit of controlling the pandemic.

Meanwhile, more information is needed on potential side effects or adverse effects from a booster shot, experts said.

The Biden administration Tuesday announced Americans should get a COVID vaccine booster dose eight months after they received their second shot, despite consensus among U.S. health experts last month there wasn’t enough data to recommend boosters for the general population.

Yep! Pharmaceutical companies + their CEOs have made billions from COVID vaccines, massive compensation packages + questionable stock sales while reassuring investors that plans were underway for boosters and annual shots.https://t.co/ydmME541qp

— Robert F. Kennedy Jr (@RobertKennedyJr) August 17, 2021

Officials announced Wednesday U.S. health leaders were preparing to offer booster shots to all eligible Americans in a plan outlined by Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle Walensky, U.S. Food and Drug Administration (FDA) acting Commissioner Dr. Janet Woodcock and Dr. Anthony Fauci, White House chief medical advisor.

The plan is still subject to approval from the FDA and the CDC’s vaccine advisory committee, but officials say they are prepared to begin the rollout of booster shots starting the week of Sept. 20.

[…]

Via https://childrenshealthdefense.org/defender/scientists-booster-shots-weak-evidence-vaccine-resistant-variants/

Hospital ‘hits breaking point’ after firing 150 unvaccinated workers

By Art Moore

WND

Shortage comes amid flood of COVID patients

The 150 nurses and other hospital workers at Houston Methodist Hospital who were fired for refusing to receive one of the expermimental COVID vaccines apparently were regarded by administrators as disposable.

But two months later, the hospital is one of several in the area experiencing a severe shortage of medical personnel as media report local hospitals have reached a “breaking point” because of a flood of COVID-19 cases, noted the Foundation for Economic Education.

The Houston Chronicle said an editorial published Tuesday the 25-county hospital area that includes Houston had more patients in hospital beds than at any point in 2021. But local KHOU-TV reported medical tents erected outside of Lyndon B. Johnson Hospital are vacant because of a shortage of nurses.

[…]

Via  https://www.wnd.com/2021/08/hospital-hits-breaking-point-firing-150-unvaccinated-workers/

Taliban Bans Cultivation and Production of Narcotics in Afghanistan

Middle East in 24

The Taliban said that Afghanistan would stop producing all kinds of drugs, and that it would work to make Afghanistan free of drugs.

At a press conference in the capital, Kabul, the movement’s spokesman, Zabihullah Mujahid, said: “Afghanistan will not produce any types of drugs. It will not be possible for anyone to participate in organizing drug smuggling. As of this moment, Afghanistan will be a drug-free country.”

Mujahid said that the country will need the help of the countries of the world so that local farmers have the ability to produce other crops instead of growing poppies, pointing out that the “Taliban” fighters control the entire borders of the country, adding that no one will attack the neighboring countries from the land of Afghanistan.

He also announced full security for embassies, foreign representations, international missions and agencies, adding that the new authorities had issued a decree of general amnesty.

A spokesman for the movement revealed that the Afghans, who cooperated with the United States and its allies, will not be harmed, indicating that the “Taliban” does not want them to leave the country.

He also affirmed the Taliban’s determination to ensure the representation of all components of Afghan society in a future Afghan government, stressing that the movement pledges to respect the religious beliefs and spiritual values ​​of all Afghans, and to guarantee women’s rights within the framework of Islamic law and law.

[…]

Via https://middleeast.in-24.com/News/169915.html

Who were the First Populists?

A Skeptics View of American History

Episode 11 Misconceptions About the Original Populists

By Gerald Stoler PhD (2012)

Film Review

In this lecture (in my view the least accurate), Stoler traces the history of America’s original populists, ie The People’s Party (aka The Populist Party). The latter flourished in the 1890s.

Stoler incorrectly states the Populists’ primary demand during the 1892 presidential election was to increase the money supply via unlimited silver coinage. According to Lawrence Goodwyn in The Populist Moment, this was only a secondary campaign issue. According to Goodwyn, the Populists main demand was to end the creation of money by private banks by abolishing the national banks created under the National Banking Acts of 1863 and 1864.*

Had they captured the presidency and congress, they would have directed the US Treasury (as stipulated in the US Constitution) to take over from private banks in issuing legal tender treasury notes.

The Populist Party grew out of a period in which most of the US population still lived on farms, and in which most farmers borrowed in the spring to pay for fertilizer, seed and farm machinery and repaid their loans after the fall harvest. The 1880s and 1890s were a period of severe deflation (ie inadequate money in circulation), in which a drop in crop prices made it extremely difficult for farmers to repay their debts.

Stoler also fails to correctly identify the cause of this historic deflation, namely a sudden contraction of the money supply triggered by a demand from Eastern banks that the post Civil War government retire $450 million in treasury notes that Lincoln issued to pay for the Civil War.

The Populist Party received one million popular votes in the 1892 election, as well as capturing numerous senate and congressional seats, governorships and state legislative seats.

In 1896, the Populist Party endorsed the Democrat’s Free Silver candidate William Jennings Bryan for president. Bryan would lose in a landslide to William McKinley.

*These laws allowed private banks to issue paper money backed (and printed) by the US Treasury “proportionate” to capital (usually US Treasury bonds) banks had on deposit with the Comptroller of Currency at the Treasury. As a general rule, these banks were allowed to issue nine times as much money as they held on deposit. This essentially granted them total control of the amount of money in circulation. See (The Populist Moment by Lawrence Goodwyn https://stuartbramhall.wordpress.com/2017/01/27/populism-americas-largest-mass-democratic-movement/)

https://pukeariki.kanopy.com/video/misconceptions-about-original-populists

Sneak Preview: RFK, Jr. Shares Details About His New Book, ‘The Real Anthony Fauci’

By  Children’s Health Defense Team

On the “RFK Jr. The Defender Podcast,” Robert F. Kennedy, Jr. shares details about his new book, “The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health,” with Robyn Openshaw, author and founder of GreenSmoothieGirl. The book, which will be released Nov. 9, is now available for pre-order.

In his upcoming book, “The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health,” Children’s Health Defense Chairman Robert F. Kennedy, Jr. gives a provocative exposé of the true Anthony Fauci, and how he used U.S. public health agencies to fund dangerous gain-of-function research that can be used to create bioweapons.

In an interview on the “RFK Jr. The Defender Podcast,” Kennedy and Robyn Openshaw, author and founder of GreenSmoothieGirl, discuss the Nov. 9 release of Kennedy’s new book, and how pre-ordering a copy today will help break through the censorship and support Children’s Health Defense, which will receive 100% of proceeds from the book sales.

Kennedy and Openshaw discuss at length the ties — and the implications of those tie —  between the National Institute of Allergy and Infectious Diseases (NIAID), headed by Fauci, and the military, which provides substantial funding to NIAID.

The two also discuss how Fauci has played a key role in “agency capture,” said Kennedy, which is the pharmaceutical industry’s coup d’état against democracy. Kennedy explained how NIAID is one of 24 agencies in the U.S. Department of Health and Human Services that’s been subject to industry capture.

Kennedy said:

“That is when the agency becomes the sock puppet for the industry it’s supposed to regulate. It’s a dynamic that happens with almost every regulatory agency. With public health agencies we see agency capture on steroids. That’s because the agency is really part of the industry.”

Nearly half of the Centers for Disease Control and Prevention’s budget comes from buying, selling or distributing vaccines, said Kennedy. “It’s the biggest vaccine distributor in the country.”

The National Institutes of Health (NIH) and the NIAID also own royalties on pharmaceutical profits, including vaccines, Kennedy said. “These are no longer regulators. It’s a polite fiction to say NIH does public health. It does not do public health. It does pharmaceutical promotion,” he said.

[…]

Via https://childrenshealthdefense.org/defender/rfk-jr-podcast-robyn-openshaw-sneak-preview-new-book-the-real-anthony-fauci/

Big Pharma Eyes Next Childhood Vaccine Cash Cow — mRNA Vaccines for RSV

By Children’s Health Defense Team

Now that COVID vaccines have established mRNA technology as the “new frontier for vaccine development,” pharma giants have set their sights on an mRNA vaccine for respiratory syncytial virus (RSV) — which they hope to add to an already overburdened childhood vaccine schedule.

Over the decades since childhood vaccines began rolling out on a widespread scale, pediatric vaccine injuries have left many parents regretful for forgetting or ignoring a basic history lesson.

That lesson, in the words of Harvard medical historian David Jones, is that “when it comes to vaccines and immunization … there always has been a risk and there always will be a risk.”

Sixty-five years ago, families learned about the risks of medical experimentation the hard way when they allowed researchers to use their infants as test subjects for a vaccine against a newly discovered illness dubbed “respiratory syncytial virus” (RSV), a common-cold-like illness now considered to affect “virtually all children,” mostly uneventfully, by age two.

The disastrous RSV vaccine led to the death of two infants and to hospitalization for the majority of other young clinical trial participants.

Since that time, vexed researchers have continued to deploy “trial-and-error approaches.” But they admit the “road to an effective RSV vaccine is paved with challenges,” in large part because of the tricky problem of “vaccine-associated disease exacerbation” — a problem that has also plagued coronavirus vaccines.

The gist of the “exacerbation” issue, also called antibody-dependent enhancement or pathogenic priming, is that the vaccine “primes” recipients to later develop more severe disease instead of protecting them.

Lured by the prospect of a large untapped global RSV vaccine market, manufacturers are nonetheless setting their sights on RSV vaccine development — and not just for infants but also for pregnant women and the elderly.

By 2019, capitalizing on the proliferation of new vaccine technologies, clinical trials were evaluating an estimated 30 candidate RSV vaccines, and scientists were gleefully announcing that the world “might be on the brink of clinical implementation soon.”

The crowded field of RSV vaccine candidates includes messenger RNA (mRNA) vaccines. In fact, with COVID injections having opened the floodgates to establish mRNA technology as the “new frontier for vaccine development,” pharma giants appear more confident than ever that they are close to finally producing an RSV winner.

In a nod to these hopes, the U.S. Food and Drug Administration (FDA) has just granted fast-track designation to Moderna for the company’s experimental mRNA-1345 vaccine against RSV. Although the fast-track FDA review applies only to older adults for now, Moderna’s phase 1 trials of its RSV injection also include children as young as 1 year old.

What about safety?

The 1960s RSV vaccine was a disaster in terms of safety, but researchers engaged in subsequent RSV vaccine attempts have tried to steer public attention away from risks and toward a single-minded focus on effectiveness.

With the help of industry-standard study design tricks — such as monitoring adverse events for only a short while or comparing the vaccine against immune-activating aluminum adjuvants or other vaccines (rather than an inert placebo) — manufacturers have managed to keep potential safety problems in the shadows.

The foundational ethical standards underpinning research on human subjects demand special attention to vulnerable populations, including fetuses, neonates, pregnant women and the institutionalized elderly.

Yet these are precisely the populations that RSV studies have targeted — all flops, with none leading to a licensed vaccine and a bare minimum of disclosure about safety.

[…]

Via https://childrenshealthdefense.org/defender/big-pharma-childhood-mrna-vaccine-respiratory-syncytial-virus/