Wednesday, November 08, 2023

What Made COVID-19 Vaccines 'Safe and Effective?

By Clare Pain

I am an Australian medical journalist with over a decade’s experience, who is also a UK citizen.

In September and October 2022 I tried to pitch this story raising concerns about the level of information given to the public when the COVID vaccines were rolled out in December 2020 and early 2021.

I submitted it sequentially to the conservative Sunday papers: The Sunday Telegraph, the Sunday Times, the Sunday Express, and the Sunday Mail.

Obviously, I did not expect that these world-famous newspapers would automatically publish anything I write! However, as a seasoned journalist, I do expect an acknowledgement and polite rejection of my pitch.

For all four newspapers there was no acknowledgement of my email, despite follow up. It was as if I had never sent it.

The aim of the story at that time was to inform people that, even at the beginning of the rollout, a reading of the UK Public Assessment Reports should have raised serious concerns about these new genetic vaccines. But it seems people were not ready for this information then.

But now the mood is changing. Many people know someone who has been injured by the vaccines, and we all know they do not stop transmission. Maybe they will be open to reading this story now?

Here's What I Wrote in 2022

The COVID-19 vaccines have been part of our lives for over 21 months, yet few people realise how different they are from vaccines we have used before.

During the first two years of the pandemic, I was a medical journalist writing for GPs and specialist doctors. I had not come across an mRNA vaccine and I had not heard of a DNA viral vector vaccine.

Nevertheless, like most of us, I was very relieved when the vaccines arrived in December 2020, because my dad was 87 and vulnerable.

Now, almost two years later, I think that the government should have been more transparent about the technology they were rolling out.

Some of us had Pfizer or Moderna injections, for instance, not knowing that a vaccine using mRNA (messenger ribonucleic acid) technology had never been approved for use in humans before COVID.

AstraZeneca (AZ) used a different technology, based on DNA (deoxyribonucleic acid). Only two similar vaccines for humans had been approved in the world prior to the AZ vaccine. These were in 2019 and 2020 for the rare and deadly disease, Ebola.

The three COVID injections differ from conventional vaccines because they use gene technology. A small piece of genetic code—in either mRNA or DNA form—is packaged and injected into our arms.

That genetic code tells our bodies to make the spike protein that protrudes from the virus particle. This protein is then recognised as foreign, and our bodies learn how to mount an immune response to it.

That should make us better prepared if we encounter a coronavirus bristling with spike proteins later in our lives.

So, why take this roundabout route of getting our bodies to make the spike protein instead of simply injecting a small amount of the protein as you might with a conventional vaccine?

It’s all about the ease and cost of vaccine production.

First, making DNA and mRNA is relatively easy and can be done quickly. It’s much simpler to do than making a conventional vaccine—that is normally done either by making an inactivated form of the virus or by isolating a protein from it.

Both viruses and proteins are delicate things that must be kept in a precise shape to be useful, so manipulating them to make a conventional vaccine can be tricky.

Unknown Unknowns?

It’s clear that genetic vaccines may be attractive to pharmaceutical companies because they provide a cheaper and more rapid route to market. And making vaccines to tackle new threats more quickly has obvious advantages for us all.
But, of course, we must be sure genetic vaccines are as safe and effective as conventional ones.

With any new technology, there may be new risks, some of which might be “unknown unknowns.”

The biochemistry of the human body is complicated, and a wise medical researcher expects surprises.

What’s more, people differ, so a drug or vaccine that has no side effects for most people may seriously harm a few. This is the reason safety trials include large numbers of participants.

Science is all about asking questions and then doing experiments to answer them. Here are just five of many questions about the genetic vaccines now being raised by people around the world.

First, how much spike protein do people make after a shot? And do different people make different amounts?

Second, how long is the DNA or mRNA active in our bodies? One thing we do know is that both Pfizer and Moderna use a synthetic mRNA that contains N1-methylpseudouridine. This makes the synthetic version last longer than normal mRNA.

Third, it would be nice to be sure that the genetic vaccine stays in the arm muscle and doesn’t reach other parts of the body. There could, for instance, be some organs in the body where making spike proteins would not be a good idea.

Fourth, could this new type of vaccine be harmful in ways that a normal vaccine would not be?

And fifth, when they were rolled out, did we have evidence that the vaccines stopped people from transmitting the virus to others? This is important because we were encouraged to get the injections so that we wouldn’t put other (vulnerable) people at risk.

Is the Devil in the Details?

To try to answer these questions I turned to the public assessment reports (PARs)—a weighty 352 pages in all!
These reports are produced by the UK's Medical and Healthcare Products Regulatory Agency (MHRA) when it approves a drug or vaccine, and they give the evidence behind the approval decision (the PAR for the Moderna vaccine was produced by the European Medicines Agency).

All three PARs have been publicly available on the UK government’s website since early in the rollout. Pfizer's was first published on Dec. 15, 2020, AstraZeneca's on Jan. 5, 2021, and Moderna's on Feb. 19, 2021.

None of the PARs show how much spike protein is made in a person's body or how long the DNA/mRNA remains active, so, unfortunately, we draw a blank in answering questions one and two.

The PARs did provide some information from animal “biodistribution” studies that suggest the vaccines may not just stay in the arm muscle.

We are told, for instance, that “low levels” of DNA from the AZ vaccine “were detectable in bone marrow, liver, lung and spleen” of laboratory mice (pdf).

For Moderna (pdf), no biodistribution studies were reported with the COVID vaccine itself, but a study of a similar vaccine was reported.

This showed that in rats, “low levels of mRNA could be detected in all examined tissues except the kidney.” We are told this included the liver, heart, lungs, testes, and brain and that higher levels were seen in the spleen and eye. We don’t know about ovaries because no female rats were tested.

A mouse study for the Pfizer vaccine suggested it reached the liver (pdf). We are told that information on “potential distribution” to other sites had been submitted to the MHRA, but it was not reported.

On the fourth question, whether the vaccines could do harm, we must remember that safety monitoring of people who were injected in the trials was carried out for just two months after the second dose. No long-term safety data was available.

No animal studies were done to see whether the mRNA/DNA in the vaccines could damage our genes (genotoxicity), according to the Pfizer and AZ documents.

For Moderna, a standard genotoxicity test of a similar mRNA vaccine in rats was done that showed raised levels of micronucleated red blood cells. This can be a signal of genotoxicity,but it can also be caused by other things. It was mentioned that genotoxicity data had been submitted for the COVID vaccine itself, but that did not seem to be reported.

Meanwhile, none of the genetic vaccines were tested to see whether they might increase the risk of cancer (carcinogenicity).

Indeed, for our latest approved “Autumn booster” vaccine, the Moderna bivalent Spikevax, the information leaflet for healthcare professionals (pdf) says “Carcinogenicity studies were not performed.”

By the way, the regulators mentioned a “theoretical risk” of Vaccine Associated Enhanced Disease (VAED) for all three vaccines. In other words, the MHRA and EMA were alert to the possibility that vaccination might make people get COVID more severely.

There was no evidence from the trials that this was occurring, but all three PARs say that the vaccine makers were instructed to keep monitoring for VAED.

Moving on to efficacy.

It’s important to be clear about what the word “effective” meant when the vaccines were rolled out.

Strictly, a vaccine can only be described as effective if it works in a real-world situation.

The original trial data could not show that the vaccines would be “effective” at promoting immunity in people such as the very sick and frail, people with immunodeficiencies, pregnant women, and young children, because people like this were not included.

Furthermore, the trials told us only that the vaccine was effective for two months against the strains of the virus that people encountered during 2020 (the year in which the trials were done). Anything else was a hope.

So when the government said they were effective, what exactly were the vaccines effective at doing? Stopping transmission of the virus; preventing people from getting COVID; or preventing severe disease and death?

Here’s what the trials showed.

If we amalgamate the data across the three vaccines, nearly 41,000 people in total were given two doses of a vaccine, while the same number received a placebo.

In the two groups—those vaccinated and those given a placebo—the number of people who developed symptomatic confirmed COVID was measured over a defined period. This window began one or two weeks after the person had received their second dose and ended two months after that dose.

While about 600 people in the placebo groups got COVID, only 100 did so in the vaccinated groups.

Symptomatic or confirmed COVID was defined slightly differently for each vaccine but boiled down to having one or two COVID symptoms (such as a temperature above a stated level, a new cough, loss of smell, etc.) plus a positive PCR test.

The Moderna trial data also indicated protection against severe COVID, with 30 of the 185 cases in the placebo group being classed as severe versus none of the 11 cases in the vaccinated group.

Could We Pass COVID on to Granny?

Turning now to the question of transmission, none of the trials were designed to test whether the vaccines could reduce the passing of the virus from one person to another. Indeed, the Pfizer PAR makes no mention of transmission.

The AstraZeneca PAR describes how rhesus macaque monkeys were vaccinated and then exposed to the virus. The vaccinated monkeys had a reduced viral load in their lungs but were still shedding the same amount of virus from their noses.

“These data support an interpretation that [the AZ vaccine] may not prevent infection nor transmission of SARS-CoV-2, but it may reduce illness,” the PAR authors wrote.

Later in the AZ document, it is said that data looking at the broadest definition of COVID infections in the human trials “suggests” a possible effect of the vaccine on transmission. However, the reasoning behind this statement is unclear, and more data was requested by the regulator.

Meanwhile, the Moderna PAR states that the effect of the vaccine on viral transmission cannot yet be determined, and “therefore the possibility for achieving herd immunity has not been demonstrated at the present time.”

So, it seems fair to say that when the vaccine rollout began and we bared our shoulders to protect granny, evidence that we would indeed protect her was scant.

A Trojan Horse?

Looking back to December 2020, when many of us rejoiced at the arrival of former Prime Minister Boris Johnson’s “scientific cavalry” that would rescue us from COVID-19, was it made clear to us and our doctors that we were rolling out a new genetic approach to vaccination? Or was that perhaps—keeping the equestrian theme—a Trojan horse?

To ask about this, I emailed the UK Health Security and Protection Agency. There has been no response to date, so I turned to the information currently provided on .

In the government’s guidance for health professionals (pdf), I have been unable to find mention that the mRNA vaccines were a world first.

And for the rest of us, assuming the current consent forms (pdf) for adults have not been materially changed, there was no explanation of how the injections worked, nor was there an alert that a completely new approach to vaccination was being rolled out.

I wonder, now, whether our doctors and nurses knew enough to properly inform their patients about these genetic vaccines. And I wonder, too, how many people’s informed consent consisted of knowledge of just three words: “safe and effective.”




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