Fauci: COVID vaccines use brand new technology

WINDOW ROCK, Ariz.

In an exclusive interview with the Navajo Times, Dr. Anthony Fauci confirmed that two companies, Pfizer Inc. and Moderna Inc., are using new and advanced “messenger RNA” technology in their COVID-19 vaccine clinical trials.

No “mRNA” vaccine has ever been approved for use in humans prior to the 2020 trials.

Fauci is the director of the National Institute of Allergy and Infectious Diseases and serves on the White House Coronavirus Task Force. RNA, or ribonucleic acid, is found in all living organisms and holds genetic information for many viruses. Its main function is to act as a messenger, carrying instructions from DNA for synthesis of proteins. Fauci explained that when the Chinese first isolated the coronavirus in January, they put the genetic sequence of the virus on a public database.

That was the moment that the race for a COVID-19 vaccine began. Scientists from both Pfizer and Moderna were able to “pull out the gene” from the coronavirus sequence that codes for a particular coronavirus protein, called the “spike” protein, said Fauci.

Now that gene code, or mRNA, copied and manufactured in a synthetic form, is what is being used in the Pfizer and Moderna vaccines to give instructions to human cells to stimulate the creation of the coronavirus “spike” protein. “If you inject the messenger RNA into the muscle, that messenger RNA starts coding for the spike protein, and makes the spike protein in the context of your normal body cells,” said Fauci.

The body then recognizes the spike protein and mounts a potent immune response to it, he said. The “neutralizing antibodies” that are created in the process are what could protect people if they are exposed to COVID-19. Fauci said that while mRNA is a new technology, it is highly efficient and it might actually give a better immune response than just injecting the protein itself.

“Remember, this is not the virus that’s being injected into a person,” he said. “It’s the messenger RNA that will code for just one of the proteins of the virus.” Since the mRNA vaccines do not contain pathogens, they are not infectious. Therefore it is impossible to give somebody COVID-19 from this vaccination, said Fauci.

“It’s aimed at inducing in the body a strong response to protect you against being infected with the coronavirus,” he said. Fauci said “back in the old days,” before these brand new technologies emerged, you would either inject a “killed virus” or an attenuated (weakened) virus through a vaccine.

“In the era of molecular biology and being able to do things in a much more precise way, right now you have is this new capability of making a vaccine that selectively induces the body to make a response against a very specific part of the virus,” he said.

Fauci is optimistic and said, “very good things have to start somewhere.” “Just because there’s no approved vaccines using messenger RNA yet, if and when this becomes successful, people will be saying, ‘Yeah, you see, it’s a good vaccine,’” he said.

Fauci says safety is obviously an important issue. “That’s the reason why, when you make a decision as to whether or not to approve a vaccine, you’ve got to do a clinical trial first,” he said. “You never know it’s safe, unless you carefully do a clinical trial, and whenever there’s an indication of adverse event, you pause the trial to see whether it was related to the vaccine or something else.”

Trial on Navajo

A technical briefing report on the Pfizer COVID-19 vaccine presented to the Health, Education and Human Services Committee last week by Dr. Laura Hammitt, who is overseeing the Pfizer Phase 3 vaccine trial on Navajo, refers to the mRNA technology as well.

Hammitt is director of Infectious Disease Programs at the Johns Hopkins Center for American Indian Health, and her reports are available by request to committee. “This is a mRNA vaccine,” her report says. “mRNA is the code that tells cells what to build. The vaccine tells cells to build coronavirus spike protein so that the body can produce antibodies and be prepared to fight the real thing.”

Hammitt’s report also says that the RNA does not integrate itself into the host genome (in other words, the conspiracy theory that the vaccine will “alter your DNA” is not true) and the RNA strand in the vaccine is degraded once the protein is made.

In the studies done so far, the Pfizer mRNA trial vaccine has been shown to induce a strong immune response to the spike protein. Hammitt confirmed that while there are already several licensed RNA therapies that are used for treatment of diseases, the mRNA vaccines (used for prevention of disease) being studied in clinical trials now could lead to licensure if approved by the FDA.

“Over the last 10 years, a number of innovations in the field of vaccinology have made this (RNA) approach possible,” Hammitt told Navajo Times. “The COVID-19 mRNA vaccines are the first large scale evaluation of this platform.” Hammitt’s report states that RNA vaccines are much quicker and simpler to make than conventional vaccines, which is one of the reasons the trials have been able to move forward at such an accelerated pace. The Navajo Nation Human Research Review Board approved the Pfizer clinical trial for Navajo in August of 2020.

‘The way out’

Both Fauci and Hammitt believe that the only way out of the pandemic is a vaccine. “If we really want to return to a state of normality that resembles where we were before COVID, you have to have a combination of good public health practices together with a safe and effective vaccine,” said Fauci.

As of Tuesday, over 200,000 people in the United States have died from COVID-19 infection. Fauci said waiting for “herd immunity,” the point where so many people have gotten infected that the virus doesn’t have any place to go anymore, is not a good option.

“If you do accept that, then it’s a failed policy,” said Fauci. He said Sweden and the United Kingdom tried to go for herd immunity and it did not work. Fauci says that it’s important for various demographic groups to participate in vaccine trials, particularly minority populations that have been disproportionately impacted by the coronavirus, to make sure the vaccines work effectively in those groups.

Based on hospitalization data reported by the CDC, Fauci said the likelihood of getting severe complications from COVID-19 is more than four times greater in American Indian and Alaska Natives than in non-Hispanic whites.

Treatment and prevention

Fauci said there are two definitively proven treatments for those COVID-19 patients who are hospitalized with lung involvement and advanced disease. One is Remdesivir, a direct antiviral drug that has been shown to decrease the time to recovery.

The other is the anti-inflammatory medication Dexamethasone, a steroid, used in COVID-19 patients who are on ventilators or require oxygen. Fauci said there are multiple other clinical trials happening for interventions that are given to COVID-19 patients early on to prevent them from having to be hospitalized.

These include monoclonal antibodies, hyperimmune globulin and convalescent plasma therapies, where antibodies that are derived from those who have recovered from coronavirus are transferred to sick patients. Fauci said he does not believe that Hydroxychloroquine, which was promoted by President Donald Trump, is a viable therapy.

According to the CDC, the drug is an arthritis medicine that can also be used to prevent malaria. “The overwhelming data and the literature indicate that Hydroxychloroquine is not an effective treatment for COVID-19,” he said.

In terms of prevention, Fauci said getting enough rest, eating right and avoiding stress are key to staying healthy overall. “I think just normal, healthy practices of good nutrition, good sleep, good exercise are important,” he said.

He believes taking Vitamins C and D can be helpful, but added that there aren’t many supplements that will boost your immune system unless you already have a deficiency. Fauci advised that while awaiting the results of the vaccine trials, everyone should continue to practice the public health measures that have brought infection rates down, including universally wearing masks, avoiding close contact and crowds, and washing your hands.

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