COVID-19 Vaccine was available in September. Dems Blocked it.

COVID-19 vaccines were formulated and trialed by May 2020. Voluntary vaccination of the elderly could have started in September. Biden, Harris, Pelosi, Cuomo, and other Democrat leaders delayed the vaccinations by two months. They issued threats, spread fear, uncertainty, and doubt regarding a “Trump vaccine”, and they used their influence within the FDA to create new, excessive, and ever-changing requirements for the vaccines’ emergency authorizations.

They put President Trump in a no-win position. If Trump used his Presidential powers to stop the delays, Democrat leadership would allege that the “Trump vaccine” is not safe, that it is being politicized, and it cannot be trusted. Big Tech would quickly deplatform anybody siding with the President, and the downstream MSM would amplify the Democrat leadership’s message. In essence, they would have denigrated the COVID-19 vaccine the same way they did Hydroxychloroquine.

Thus, Trump had no choice but to go along with the Democrat leadership’s plan to delay the announcement of a successful vaccine until late November, and its approval until December.

Overview

mRNa Technology

The development and manufacturing of the coronavirus vaccines, at an unprecedented speed, was made possible due  to the novel mRNA technology. The proof-of-concept behind mRNA technology was in 1990. The technology needed a long time to properly develop to the point where it could be practically used. Moderna was established in 2010 to develop commercially viable mRNA products. Multiple mRNA vaccines have been developed and have passed Phase 1 trials in the last few years, but no vaccines were authorized before the COVID-19 vaccines from Pfizer/BioNTech and Moderna.

mRNA vaccines are considered safe, based on the mechanism of preparation and action, and limited trial data. The unique advantage of an mRNA vaccine is that it can be developed within a few weeks, and manufacturing can be ramped up very quickly. Moderna’s pipeline contains multiple vaccines and anti-cancer products using mRNA technology.

Pfizer/BioNTech and Moderna COVID-19 vaccines, which were authorized just this month, December 2020, were formulated in January-February, based on the published genome of the Wuhan coronavirus.

In April, Pfizer CEO announced that their COVID-19 vaccine might be available in September, 2020. It was important to start vaccination in early fall before the beginning of the cold and flu season.

Democrats Delay the Vaccine

However, not everybody wanted a COVID-19 vaccine delivered in the early fall. Democrat leaders announced that they would not trust a “Trump vaccine,” and demanded longer, larger, and more stringent trials, than normally required for an emergency authorization. They also demanded a longer authorization process. The FDA obliged, contrary to its mission:

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices … FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable …”

Thus, the FDA’s responsibility was to speed up the emergency authorization of a COVID-19 vaccine. This fact is frequently forgotten, but providing medical advice is outside of the FDA’s scope of responsibilities and authority. Taking or not taking a vaccine, or any other treatment, is a personal decision, made in consultation with one’s doctor.

It is important to note that the FDA imposed excessive demands on vaccine developers (see below), effectively guaranteeing that no vaccine would be announced before the November elections. After Pfizer applied, the FDA spent another 3+ weeks reviewing it. A long review was another delay the Democrats inserted into the authorization process. This is in vast contrast to the EUA for Remdesivir, which was issued before the completion of the first clinical trial (Beigel et al.), and even though the drug had already failed multiple times.

In September, nine leading pharmaceutical companies, including Moderna, Pfizer, and BioNTech, signed a weird pledge, agreeing not to question or appeal decisions made by the FDA, no matter how harmful, onerous, or insubordinate they are. On October 6, the FDA made exactly such a decision, arbitrary effectively setting the earliest application submission date to the third week of November.

Vaccine Approval Process

When reviewing a prospective treatment, there are two considerations: effectiveness and safety. The requirement of 50% effectiveness for the COVID-19 vaccine was reasonable. Both vaccines are 95% effective. Given such high effectiveness, and considering the urgency, it was not necessary to wait until the pre-defined endpoint. Apparently, the Trump administration was aware of the Pfizer/BioNTech vaccine effectiveness when it ordered 100 million doses, on July 22.

Safety is as important as effectiveness. Generally, vaccines should be safer than drugs, because they are administered to potentially very large numbers of healthy people, with a low risk of the disease. In the case of the Wuhan coronavirus, the FDA could have issued the EUA for the vaccine for people 65+ (or 65-85, the age bracker selected in a trial). In this age bracket, the risk of infection and severe COVID-19 disease is high and justifies the lower safety requirements typical of life-saving drugs. Remdesivir, which was quickly approved by the FDA because it allegedly shortened hospital stay by four days, was not considered a life-saving drug. Nevertheless, it received a EUA before the completion of its clinical trial on ~500 patients. Moderna and Pfizer/BioNTech vaccines were trialed on tens of thousands of people each. By mid-September, there was enough data from the Phase 3 trial for the FDA to issue a EUA to Pfizer. It could have restricted it to the 65+ age bracket and described all adverse effects. It could have also limited the number of doses produced. 1,000,000-2,000,000 vaccines, given in September-October to volunteers (age 65+), with preference given to healthcare workers, would have been another game-changer.  This would have probably eliminated most of the COVID-19 mortality in November-December because each prevented case also breaks a chain of transmission.

Again, the FDA’s duty was to accelerate the process, authorize the vaccine(s) that have an acceptable effectiveness/risk ratio, even if it was for only a portion of the population, and to document the adverse effects. No one was mandating these vaccines. If Pelosi, Cuomo, Newsom, and their accomplices do not trust a vaccine authorized by “Trump’s FDA”, they are free to conduct additional private or state-sponsored trials, or to simply not use this vaccine. Notice that Newsom and Cuomo do not grant  this same choice to the parents in their states, but instead force them to vaccinate their children with whatever vaccines have been authorized, without any transparency or even attention given to the process. The Democrat leadership is also free to develop a vaccine of their own, and demand that the FDA fast-track its authorization as well. But they cannot legally block tens of millions of Americans from voluntarily getting an efficient and acceptably safe vaccine. The President’s duty is to direct the FDA. Pelosi and other Democrat congresspersons are interfering with it.

Supporting Documents and Timelines

Selected Vaccines Development Events

March 16: (Moderna) NIH clinical trial of investigational vaccine for COVID-19 begins (NIH)

“The first participant received the investigational vaccine today.”

April 22: Pfizer, BioNTech Covid Vaccine Cleared for Human Tests (Bloomberg)

April 23: “the first subject was vaccinated with BioNTech’s mRNA vaccine candidate(BioNTech)

April 29: Pfizer says coronavirus vaccine could be ready for emergency use by fall | TheHill

“Pfizer and German pharmaceutical company BioNTech have developed a coronavirus vaccine that could be ready for emergency use as early as September, Pfizer’s CEO told The Wall Street Journal Tuesday. “

May 30: (Pfizer) Another coronavirus vaccine candidate might be ready sooner than expected – BGR

““If things go well, and the stars are aligned, we will have enough evidence of safety and efficacy so that we can… have a vaccine around the end of October,” he [Pfizer CEO Albert Bourla] said during the event.”

June 30: Development and Licensure of Vaccines to Prevent COVID-19. Guidance for Industry. (FDA)

At the end of June, after at least two mRNA vaccines had already been developed and successfully trialed, the FDA issued new “Guidance” with excessive requirements for the vaccine manufacturers. Democrat leader, Nancy Pelosi quickly expressed support for the FDA’s new “guidance”, further casting doubt on the vaccines’ efficacy and safety.

July 22: US pays $1.95 billion for 100 million doses of Pfizer COVID-19 vaccine (usatoday.com)

July 27: Pfizer and BioNTech Choose Lead mRNA Vaccine Candidate Against COVID-19 and Commence Pivotal Phase 2/3 Global Study Nasdaq:BNTX (globenewswire.com)

July 27: (Dems) Biden Urges Vaccine Process Free from ‘Political Pressure’ – Bloomberg (archive.is)

Biden makes the following statements:

“senior career scientists and public health experts should be allowed to make public, uncensored statements and appear before Congress unconstrained to speak the truth.”

According to Biden, “free of the political pressure” means “appearing before Congress”.  He continues:

“as we enter the height of election season, President Trump should assure us all that the White House will respect the independent authority of the Food and Drug Administration to decide, free from political pressure, if the vaccine is safe and effective.”

The FDA has no independent authority. It is an agency within the executive branch, and all its authority is derived from the powers of the President. See  Article II of the Constitution.

Joe Biden and other Democrat leaders should have joined in the efforts to develop and manufacture a vaccine, and thus, shared in the credit for its success (or in the blame for the failure). Instead, they elected to sabotage it.

Biden added additional terms and conditions for the vaccine authorization, such as making the clinical data publicly available (patients’ privacy be damned), getting a separate report from the Center for Biologics Evaluation and Research, and meddling in other ways.

August 11: Moderna Announces Supply Agreement with U.S. Government for Initial 100 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273) | Moderna, Inc. (modernatx.com)

August 21: Pfizer and BioNTech’s Coronavirus Vaccine Candidate Produces Antibodies in People Up to 85 Years Old | The Motley Fool

September 30: (Dems) All Eyes Are on Pfizer as Trump Pushes for Vaccine by October (The NY Times)

““Right now, our model — our best case — predicts that we will have an answer by the end of October,” the chief executive, Dr. Albert Bourla …”

They had the answer for developing the COVID-19 vaccine in May. The “answer” that Dr. Bourla was referring to, at this time, was on how to overcome the resistance of “The Resistance”.

“The F.D.A. has also told vaccine makers that they will need to track at least half of the patients’ safety data for two months before the agency will grant emergency access.”

This was an arbitrary and capricious restriction, given that more than 40,000 participants had been recruited. The Remdesivir trial (Beigel et al.) involved only about 500 patients, who were only tracked for one month, and the EUA was issued even before those results were available.  A reasonable demand for the vaccine would have been to track the first 2,000 participants for two months, and another 10,000 for one month, before applying for the authorization.

October 6: Race for Covid-19 vaccine slows as regulators, top Warp Speed official tap the brakes

“The race for a Covid-19 vaccine slowed on Tuesday, as both U.S. regulators and the head of the Trump administration’s Operation Warp Speed initiative tapped ever so softly on the brakes. The Food and Drug Administration released strengthened rules for authorizing any Covid-19 vaccine on an emergency basis.”

“According to the revised rules, the FDA wants vaccine manufacturers to collect safety data on at least half of their clinical trial subjects for two months after they have received their second dose of vaccine …”

“Half of their clinical trial subjects” meant approximately 15,000 people for Moderna, and more than 20,000 for Pfizer. Comparatively, in the Remdesivir trial, only about 500 patients received the drug, and the EUA was issued in less than two months, which means that no patient could have been observed for two months after taking the course of Remdesivir.

This last moment requirement was totally unnecessary. Its effect was to set the third week of November as a firm earliest date for the applications. Undoubtedly, this new restriction was issued under undue influence.

October 16: An Open Letter from Pfizer Chairman and CEO Albert Bourla | Pfizer

“So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November.”

Clearly Democrat leaders and the far left succeeded in pushing Pfizer to postpone its application for EUA.

October 21: (Dems) Newsom says California will independently review coronavirus vaccine: ‘We won’t take anyone’s word for it’ (Fox News)

Late October: Pfizer stops confirming cases and drops the interim analysis that would show 90%+ effectiveness of the vaccine. The announcement would be made after the elections.

Nov 18: PFIZER AND BIONTECH CONCLUDE PHASE 3

“Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose …

Efficacy was consistent across age, gender, race and ethnicity demographics; observed efficacy in adults over 65 years of age was over 94% …

Data demonstrate vaccine was well tolerated across all populations with over 43,000 participants enrolled; no serious safety concerns observed; the only Grade 3 adverse event greater than 2% in frequency was fatigue at 3.8% and headache at 2.0%”

Moderna’s COVID-19 Vaccine mRNA-1273, Timeline

Selected events:

“Jan 13: The NIH and Moderna’s infectious disease research team finalized the sequence for mRNA-1273.

Feb 24: Moderna shipped the first clinical batch of mRNA-1273 to the NIH for use in their Phase 1 clinical study.

Mar 16: The NIH announced that the first participant in its Phase 1 study of mRNA-1273 was dosed, a total of 63 days from sequence selection to first human dosing.

Apr 27: Moderna submitted  an IND to the U.S. FDA for Phase 2 study of mRNA-1273.

600 participant Phase 2 study to begin upon IND acceptance and safety data from ongoing NIH-led Phase 1 study

May 18: Moderna announced positive interim Phase 1 data for mRNA-1273.

“mRNA-1273 elicited neutralizing antibody titer levels in all eight initial participants across the 25 µg and 100 µg dose cohorts, reaching or exceeding neutralizing antibody titers generally seen in convalescent sera

mRNA-1273 was generally safe and well tolerated”

July 27: The Phase 3 study of mRNA-1273 being conducted in collaboration with the NIH and BARDA begins

Expected to enroll 30,000 participants in the U.S. [This is 30 times more than in the Remdesivir trial]

Sep 08: Moderna signed a pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines.

[See below.]

Nov 16: mRNA-1273 met its primary efficacy endpoint in the first interim analysis of the Phase 3 COVE study with a vaccine efficacy of 94.5%”

Biopharma’s Pledge – the Opposite of the Hippocratic Oath

Sep 8: Biopharma Leaders Unite to Stand with Science (press release)

The title is funny. Did they stand against science before? Anyway, “stand with science” became a code phrase for “resist the Trump administration”.

“The CEOs of AstraZeneca (LSE/STO/NYSE: AZN), BioNTech (NASDAQ: BNTX), GlaxoSmithKline plc (LSE/NYSE: GSK), Johnson & Johnson (NYSE: JNJ), Merck (NYSE: MRK), known as MSD outside the United States and Canada, Moderna, Inc. (Nasdaq: MRNA), Novavax, Inc. (Nasdaq: NVAX), Pfizer Inc. (NYSE: PFE), and Sanofi (NASDAQ: SNY), today announced a historic pledge, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.”

This is a ridiculous pledge. Since when do biotech and biopharma companies need a “historic pledge” to uphold the scientific process? What process were they using before? Clearly, they are either making a different statement or admitting to the whole world that, until now. they did NOT “uphold the integrity of the scientific process”.  The “pledge” continues:

“The safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA). FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US. FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically, the agency requires …”

“[We pledge to] Only submit for approval or emergency use authorization 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.”

Again, this is ridiculous. The companies are not pledging to meet FDA requirements, as if they ever had a choice not to. Obviously, the signatories are not pledging to meet the regulatory requirements that they were always subject to, but instead, they are committing to a specific timeline, equally and universally delaying all vaccine authorizations until after the November Elections.

At the very least, this pledge would classify as an illegal collusive trust agreement, not only to not compete, as these companies are supposed to do, but to postpone any vaccine applications. Colluding to purposefully delay life-saving innovations, while people are actively dying, is at best a human rights violation and at worst a crime.

Other Sources

October 6: Anti-Vaxxers Feed Off Democrats’ Skepticism of COVID Vaccine (NewsWeek)

“Kennedy, a lawyer and prominent anti-vaccine activist, said that around the middle of August—when the Trump administration began suggesting a vaccine may be ready before the November 3 election—Democratic leaders started voicing skepticism about the development process for the first time.”

Obviously, the motivation for this was not to allow a COVID-19 vaccine before the elections.

“On September 24, New York governor Andrew Cuomo said the state will independently review all vaccines authorized by the federal government. 

At the start of September, Democratic vice presidential nominee Kamala Harris said she would not trust President Donald Trump’s word alone that any vaccine developed is safe and efficient.

A week later, Democratic presidential candidate Joe Biden made similar remarks during a speech in Delaware, saying, “I trust vaccines, I trust scientists, but I don’t trust Donald Trump.”

Meanwhile, Nancy Pelosi, Democratic speaker of the United States House of Representatives, has said any vaccine must meet safety standards before being released if it is to be accepted by the public.”

This article contains a short overview of the vaccine obstruction by Democrat leaders, in the couple of months prior to publication. The author appears unaware that the obstruction started in May.

May 13: Wuhan Virus Vaccines, Rud Istvan, WUWT

A lay review.

May 7: Pfizer Starts Clinical Trials of COVID-19 Vaccine (webmd.com)

Stage 1 of the phase I/II trial in the U.S. will enroll up to 360 healthy people in two age groups, 18-55 and 65-85.

July 31: Biden Questions Safety of Eventual Coronavirus Vaccine (archive.is from Townhall)

Dec 4, How key decisions slowed FDA’s review of a Covid-19 vaccine — but also gave it important data (StatNews)

There was enough data in September. The FDA elected not to look at it. Even after submission of the Pfizer paperwork in late November, the FDA wasted another three weeks, because the process was set to delay authorization.

“A STAT review of the process of vaccine development reveals only three ways it could have been further sped up. The first, and biggest, revolves around an FDA decision to require two months of safety data for half the patients in a study before a company asked for authorization. Had it settled for less data, a vaccine likely would have been authorized quicker.”

“The FDA might have also been able to save some time if it evaluated data on the vaccines on a rolling basis, instead of getting all of the information — in Pfizer’s case, tens of thousands of pages — at once.” 

“Lastly — and perhaps least consequently — the FDA could have turned around the data for its advisory committee more rapidly, holding the meetings on, say, Dec. 3 and Dec. 10, instead of Dec. 10 and Dec. 17.” 

There were many more ways to speed the process up. Sabotage by “the resistance” of embedded Democrat-Socialists, the FDA kept or added regulatory hurdles, starting in May.

“Why is the review of the data taking so long? … This type of analysis, routine for new drug approvals at the FDA, is not legally necessary for emergency use authorizations during a pandemic.” 

Sure. Remember Remdesivir? Further delays were incurred because of

“… the FDA’s decision, announced quietly on Oct. 6 in the prelude to an earlier FDA advisory committee, to tell vaccine makers not to ask for an EUA until half the patients in their studies had been followed for two months.”

Trump – Biden Debate

Sep 29, Donald Trump & Joe Biden 1st Presidential Debate Transcript 2020 – Rev

Vice President Joe Biden: (24:03)
His own CDC Director says we could lose as many as another 200,000 people between now and the end of the year. And he said, if we just wear a mask, we can save half those numbers. Just a mask. And by the way, in terms of the whole notion of a vaccine, we’re for a vaccine, but I don’t trust him at all. Nor do you. I know you don’t. What we trust is a scientist.

President Donald J. Trump: (24:25)
You don’t trust Johnson & Johnson, Pfizer?

Vice President Joe Biden: (01:28)
So here’s the deal. This man is talking about a vaccine. Every serious company is talking about maybe having a vaccine done by the end of the year, but the distribution of that vaccine will not occur until sometime beginning of the middle of next year to get it out, if we get the vaccine. And pray God we will. Pray God we will.

Chris Wallace: (01:49)
Mr. Vice President, I want to pick up-

President Donald J. Trump: (01:50)
You’ll have the vaccine sooner than that.

Chris Wallace: (01:51)
I want to pick up on this question though. You say the public can trust the scientists, but they can’t trust President Trump. In fact, you said that again tonight. Your running mate, Senator Harris, goes further, saying that public health experts quote, “Will be muzzled, will be suppressed.” Given the fact that polls already show that people are concerned about the vaccine and are reluctant to take it, are you and your running mate, Senator Harris, contributing to that fear?

Vice President Joe Biden: (02:18)
No more than the question you just asked him. You pointed out he puts pressure and disagrees with his own scientists.

Chris Wallace: (02:25)
But you’re saying you can’t-

Vice President Joe Biden: (02:26)
Everybody knows-

Chris Wallace: (02:26)
Or Senator Harris is saying you can’t trust the scientist.

Vice President Joe Biden: (02:28)
Well, no, no. You can trust the scientist. She didn’t say that. You can trust the-

Chris Wallace: (02:32)
She said that public health experts quote, “Will be muzzled, will be suppressed.”

Vice President Joe Biden: (02:36)
Yes. Well, that’s what he’s going to try to do, but there’s thousands of scientists out there, like here at this great hospital that don’t work for him. Their job doesn’t depend on him. They’re the people… And by the way-

President Donald J. Trump: (02:51)
We spoke to the scientists that are in charge-

Vice President Joe Biden: (02:53)
By the way-

President Donald J. Trump: (02:53)
… they will have the vaccine very soon.

Michael Pence to Kamala Harris

Oct 8, Michael Pence – Kamala Harris Debate

We have five companies in phase three clinical trials. And we’re right now producing 10s of millions of doses. So, the fact that you continue to undermine public confidence in a vaccine if the vaccine emerges during the Trump administration, I think is unconscionable. And Senator, I just asked you, stop playing politics with people’s lives. The reality is that we will have a vaccine … And your continuous undermining of confidence in a vaccine is just, it’s just unacceptable.  …

… and, Senator, please stop undermining confidence in a vaccine.  

Scientific Reviews of mRNA vaccination

Advances in mRNA Vaccines for Infectious Diseases, in Frontiers in Immunology, 2019 says that mRNA vaccines are relatively safe, easy to manufacture, and ideally suited for emerging diseases:

“As previously described the production procedure to generate mRNA vaccines is entirely cell-free, simple and rapid if compared to production of whole microbe, live attenuated and subunit vaccines. This fast and simple manufacturing process makes mRNA a promising bio-product that can potentially fill the gap between emerging infectious disease and the desperate need for effective vaccines.”

“Compared with the prophylactic and therapeutic application of mRNA in cancer, clinical trials of mRNA vaccines for infectious disease are still in their early age.” 

mRNA as a Transformative Technology for Vaccine Development to Control Infectious Diseases, in Molecular Therapy, 2019 says that mRNA vaccines are “on demand”:

A “vaccine on demand” approach that enables rapid development, large-scale production, and distribution of the vaccine would be desirable.

“The seminal work from Wolff et al. in 1990 provided the first successful example of in vitro-transcribed mRNA-expressing reporter proteins in the muscle after injection …”

These approaches are appropriate to produce almost any mRNA sequence, with low batch-to-batch variability, potentially saving time and reducing costs compared with other vaccine platforms. 

mRNA vaccines — a new era in vaccinology, in Nature, 2018 suggests that mRNA vaccines might be safe, versatile, rapid, scalable:

“… safety: as mRNA is a noninfectious, non-integrating platform, there is no potential risk of infection or insertional mutagenesis. Additionally, mRNA is degraded by normal cellular processes, and its in vivo half-life can be regulated through the use of various modifications and delivery methods”

“Preclinical studies have created hope that mRNA vaccines will fulfil many aspects of an ideal clinical vaccine: they have shown a favourable safety profile in animals, are versatile and rapid to design for emerging infectious diseases, and are amenable to scalable good manufacturing practice (GMP) production …”

“These observations suggest that mRNA offers a safe, simple and efficient alternative to therapeutic monoclonal antibody protein delivery, with potential application to any therapeutic protein …”

Trump’s tweets

https://twitter.com/realDonaldTrump/status/1260919777301798912 (May 14)

https://twitter.com/realDonaldTrump/status/1283374013100720128 (Jul 15)

https://twitter.com/realDonaldTrump/status/1297138862108663808 (Aug 22)

https://twitter.com/realDonaldTrump/status/1325962203346972678 (Nov 10)

via Science Defies Politics

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December 31, 2020 at 04:45PM

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