The regulations Sanders & Co. seek would destroy the incentives needed for innovation and leave us unprepared for the next pandemic.
Bernie Sanders has described pharmaceutical companies as “crooks” who are “literally killing people every day.” So I guess we have some pretty nefarious characters to thank for the unprecedentedly rapid development of safe and effective vaccines that promise to bring the COVID-19 pandemic to an end. These innovative companies have invested years of work and billions of dollars that put them in a position to create new vaccines in record time.
It normally takes ten years or more to develop new vaccines for novel viruses. But now, only ten months after China identified the hitherto unknown SARS-CoV-2 virus responsible for COVID-19 and shared its genetic sequence, 53 COVID-19 vaccines created by a variety of new and old vaccine-making techniques are being tested in humans in 18 countries. Eleven of these are in the most advanced stage of trials (Phase 3).
Two private companies have just announced promising results in their ongoing trials. On November 16, Moderna, based in Cambridge, Mass., announced that preliminary data show its COVID-19 vaccine is 95 percent effective. A week earlier New York based Pfizer with its German partner BioNTech announced their vaccine is 90 percent effective in preventing COVID-19 in a preliminary analysis. Today Pfizer announced final results indicating that its vaccine is 95 percent effective and causes only rare and mild side effects. It was effective for different races, ethnic groups, and ages — unlike many older vaccines that do not work well in the elderly, the Pfizer m-RNA vaccine was 94 percent effective in people over 65, the group at highest risk for severe COVID-19 illness and death. Pfizer plans on seeking emergency-use authorization within days. Neither the Moderna nor the Pfizer trial has reported severe side effects.
Both companies are utilizing a novel technology called m-RNA — or messenger RNA — that involves synthesizing the genetic instructions to make a protein and injecting them into patients whose own cells use the instructions to make the desired protein. Our cells naturally make m-RNA to carry protein-making instructions from our DNA. For a COVID-19 vaccine, researchers created m-RNA that codes for proteins found on the surface of SARS-CoV-2. Vaccine recipients take this m-RNA into their own cells and use the m-RNA as a template to produce the SARS-CoV-2 proteins. Vaccine recipients then make antibodies to the protein, enabling the recipient to identify and destroy the virus before it causes illness.
Moderna and BioNTech are small biotech startups that have been working over many years on m-RNA technology to make drugs to treat a variety of conditions. Both companies raised and spent billions of dollars, though their efforts to make therapeutics were largely unsuccessful. Yet both companies realized that the technology could be useful for creating new vaccines and turned their attention to that end. BioNTech entered into a research and development collaboration in 2018 with the major producer Pfizer to develop m-RNA-based influenza vaccines. Both companies are studying m-RNA vaccines for a variety of diseases including cancers.
When the COVID-19 pandemic hit, the companies quickly pivoted to creating a vaccine against SARS-CoV-2. Moderna shipped its first batch of vaccines to the NIH for Phase 1 trials on February 24, a record 44 days after the viral sequence was disclosed. Both companies began Phase 3 trials five months later on July 27.
The Trump administration aided m-RNA COVID-19 vaccine development through Operation Warp Speed, providing additional funding to Moderna in April and committing to buy up the first 100 million doses of each company’s vaccines and distribute them to patients at no cost. Pfizer has indicated that it could ship up to 50 million doses in 2020 and 1.3 billion doses in 2021. Moderna has promised up to 20 million doses this year and between 500 million and a billion doses next year. Since each vaccine requires two doses, the administration has already locked up enough doses to vaccinate 100 million people, about a third of the country. The initial doses available this year, enough to vaccinate 35 million people, can be targeted to front-line health workers and vulnerable populations such as the elderly and people with medical co-morbidities, greatly reducing the number of severe COVID-19 cases and deaths.
Progressing from discovery of a novel virus to safe and effective vaccines utilizing a new technology in just ten months demonstrates the innovative power of the private market to discover, develop, and deliver life-saving new products. The regulation and price controls Bernie Sanders and his fellow travelers prefer would destroy the incentives and profits needed for continued innovation and leave us unprepared for the next pandemic.