On June 30, the U.S. Food and Drug Administration (FDA) released guidelines for approving a COVID-19 vaccine. They are requiring the vaccine to prevent or decrease the severity of the virus in a minimum of 50% of the people who will be getting the shot.
In March, the first vaccine trials were conducted by the U.S. biotech firm Moderna. At that time, Dave O'Connor, a virologist at the University of Wisconsin-Madison shared that 'We might have vaccines in the clinic that are useful in people within 12 or 18 months. But we're going to need to improve on them to develop second- and third-generation vaccines.'
The US National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, Maryland conducted a study with 45 participants who receive a single or double dose of a developed vaccine. Meanwhile, they and other companies continue with animal studies, primarily monkey models.
Soon, more countries around the world joined the race to develop safe and affordable vaccines as the pandemic began entering its second wave in some countries. The London School of Hygiene & Tropical Medicine reported that there are currently 23 coronavirus vaccine projects that are doing clinical trials, with several already advancing to phase 2 or 3.
Operation Warp Speed
Recent developments include the biotech firm Inovio's vaccine, the INO-4800. So far it is the first DNA vaccine stable at room temperature, which triggers a specific immune system response against coronavirus pathogens.
Chosen American companies that are developing vaccines are all under the government's program called 'Operation Warp Speed', which aims to deliver up to 300 million safe vaccines by January 2021. The five companies selected for OWS include Moderna, AstraZeneca who is collaborating with Oxford University, Merck, Pfizer (partnering with the German company BioNTech), and Johnson & Johnson. The FDA said, 'While the FDA is committed to expediting this work, we will not cut corners in our decisions.'
Gregory Poland, director of Mayo Vaccine Research Group, said 'the guidelines are pretty standard, they look pretty much like influenza vaccine guidelines. I don't think that's a high bar. I think that's a low to maybe an appropriate bar for a first-generation COVID-19 vaccine.'
As Moderna is stepping into phase 3 of their trials in July, 30,000 volunteers will be receiving their vaccine. Their goal is to deliver between 500 million to one billion doses every year by 2021. At the same time, health officials have also set targets to determine if coronavirus vaccines are safe and efficient.
Roland Sutter from the World Health Organization (WHO) in Geneva, Switzerland said 'If you accept a vaccine with low efficacy, then you probably prevent the development of a vaccine with higher efficacy.'
A challenge that vaccine scientists face is that clinical trials happen in controlled environments, shared Charlie Weller from a vaccine program at Wellcome, London. She said, 'So the real test for a vaccine is when it's rolled out into a population.'
Despite American companies advancing in vaccine developments, another obstacle is educating people to actually get the shot. Dr. Fauci shared in a recent interview that 'there is a general anti-science, anti-authority, anti-vaccine feeling among some people in this country - an alarmingly large percentage of people, relatively speaking.'