Dr. Jane M. Orient, an Arizona internist who will testify before Congress Tuesday, has raised concerns about the new science that pharmaceutical companies Moderna and Pfizer are using to develop coronavirus vaccines and ongoing calls for comprehensive vaccination.
“It seems reckless to me to urge people to take risks when you don’t know the risks,” said Dr. Orient this week in an interview with the New York Times. “People’s rights should be respected. Where is ‘my body, my choice’ when it comes to it? “
Indeed, Pfizer and Moderna rely on new scientific methods for their vaccines, building them around a molecule called messenger RNA, or mRNA, a natural genetic material that directs the production of proteins in human cells. Dr. However, Orient, who heads the Association of American Physicians and Surgeons and was previously criticized for promoting anti-vaccine sentiment, is not backed by the wealth of scientific evidence.
Although no experimental vaccine has yet received the green light from the Food and Drug Administration for widespread use, both products have been extensively and carefully tested in clinical trials. Early data suggests it protects people about 95 percent from developing Covid-19, and neither has shown any serious side effects.
Both Pfizer and Moderna have filed for emergency approval with the FDA for their vaccines. The agency will be reviewing Pfizer’s case on Thursday, and many experts expect the product to receive approval. On Tuesday, the FDA released documents confirming the safety and effectiveness of the Pfizer vaccine in a wide variety of volunteers in terms of age, weight, and race. The emergency approval for Moderna’s vaccine is expected to follow next week.
The approvals would trigger a series of vaccination campaigns that are expected to extend well into 2021. Mass vaccination, which will curb the death toll from the pandemic and most likely slow the spread of disease, is an important step in the fight against the coronavirus.
“Vaccination protects you and the people around you,” said Padmini Pillai, vaccine researcher at the Massachusetts Institute of Technology. “And based on data, the virus kills but the vaccine doesn’t.”
The mRNA in these vaccines contains the blueprint for a protein found on the surface of the coronavirus. Once produced by cells, this protein acts like a molecular mug shot, teaching the immune system about the most memorable features of the coronavirus. This prepares the body to fight off the real virus in case a phone call ever comes up.
The process more or less mimics what happens when a virus infects a cell: it too has to discharge its genetic load and force the cell to produce proteins. However, unlike a virus, the mRNA is not infectious and cannot induce cells to produce active disease-causing viruses. The molecules are also fragile and don’t linger in cells long after they have been “read” to make proteins. Researchers have no reason to believe that they have a lasting impact on the human body, apart from the fact that it strengthens its defenses against infection.
Pfizer’s vaccine has already been approved for emergency use in the UK. Es and Moderna’s product are well on their way to becoming the world’s first fully licensed mRNA vaccines, although similar vaccines have been in development for decades.
None of the vaccines caused serious side effects in volunteers in clinical trials. While many recipients experienced mild symptoms after the injection, including headache, mild fever, fatigue and pain, “it just means the immune system is working,” said Dr. Pillai. “Tens of thousands of people safely received the vaccine.”
The FDA and equivalent agencies in other countries take safety seriously when considering whether to give vaccines their seals of approval. Researchers will also continue to look out for unexpected side effects as more people are vaccinated. So far, the skepticism of Dr. Orient unfounded.
Dr. Orient has also drawn criticism for their unwavering defenses against hydroxychloroquine as a treatment for Covid-19, despite overwhelming evidence that the drug has little benefit and can harm the people who receive it.
She will appear at a home-based treatment for Covid-19 before the Senate Homeland Security and Government Affairs Committee Tuesday. She told The Times this week that too often doctors sent patients home to get rid of their illness.