On Sunday, the director of the Centers for Disease Control and Prevention accepted the FDA’s recommendation for emergency use of the vaccine for those 16 and older. After several months of rising death tolls, overwhelmed hospitals, lockdown fatigue and economic strife, this is a moment to remember.
The development of new vaccines against a new virus in less than a year is an astonishing scientific achievement. As soon as the genomic sequence of the Covid-19 virus was shared by Chinese scientists in January, biotech and pharmaceutical companies immediately began making candidate vaccines. Vaccine trials began soon after, and now, in less than a calendar year, the United States has cleared a vaccine, with another from Moderna likely to follow soon.
Previously, the fastest development of any new vaccine was for mumps, which took four years; most require more than a decade. The speed of development and testing of the Pfizer / BioNTech vaccine and the name of the project, Operation Warp Speed, has raised concerns among some who wonder if we can really find out if vaccines are safe and effective so quickly.
I think the answer is yes – for two reasons: Independent scientific reviews were rigorous, and the Covid-19 vaccine race was longer than people think – more like a marathon than a sprint.
A report from the United States National Academy of Sciences in 2002 revealed how vulnerable the United States is to terrorist attacks and pandemics. As the most likely pandemic threat was a new strain of influenza, in 2005 and 2006 the government developed the National Pandemic Influenza Plan, updated over the next decade, with a detailed strategy on How to respond to a new pandemic threat, due to any influenza virus, was on the horizon.
Unfortunately, the plan appears to have been ignored by the current administration, and the pandemic preparedness team, put in place by the Obama administration in 2015, was disbanded in 2018.
However, at a scientific level, the new possibilities of DNA technology have revealed that it is possible to bypass the usual slow processes of vaccine development, by first cultivating it in large quantities, purifying and testing it. , which takes a long time. What modern genetics have made possible is to go directly from the genome sequence to the prediction of the virus components that are essential for the protection and very rapid production of vaccines containing the target genes or proteins.
The key mRNA technology was developed in the 1990s by Katalin Karikó, then working at the University of Pennsylvania. Biotech companies, who first saw the potential of new mRNA technology to treat cancer or rare diseases, soon realized after epidemics such as the H1N1 flu that they could create platforms in which the genes of any virus could be connected to quickly generate a candidate vaccine.
Their work has been supported by a large but little-known agency, the Biomedical Advanced Research and Development Authority (BARDA), established in 2006 to prepare and store vaccines against bioterrorist agents, smallpox and anthrax.
BARDA seeks to support the advancement of medical innovation, including new vaccines against emerging viruses, and has funded companies developing these new platforms at an early stage to accelerate the process.
Before Covid19 was known, BARDA helped fund mRNA vaccines against viruses like influenza, Zika, and respiratory syncytial virus (RSV), although no mRNA vaccines were approved by the FDA.
Then Covid-19 struck. Based on knowledge about the SARS-associated coronavirus, scientists guessed the key Covid-19 protein to be targeted by vaccines and, using genetic engineering, plugged key genes into their new platforms and made shown to be safe in animals and effective in preventing disease. Thus, the planning of the new Covid-19 vaccines took place long before the virus was known and the technical knowledge of the platforms paid off to allow the creation of vaccines in record time.
Even before knowing the outcome of the Covid-19 vaccine trials, the government agreed to purchase hundreds of millions of doses of six new vaccines, if they were found to be safe and effective, to cover their bets on which would work. better. And with these advance purchase agreements, companies could increase production.
While the science has evolved faster than ever before, the requirements for emergency use clearance from the FDA have remained as stringent as for any previously approved vaccine. We know that almost all vaccines produce minor vaccine reactions such as sore arm, fatigue, fever in some people which goes away within a day or two, and the initial UK vaccinations found very few people with a history of allergic reactions had a more serious vaccine reaction.
Even more promising, Pfizer and Moderna each reported that their vaccine was around 95% effective in preventing Covid-19 disease in clinical trials.
Finally, after a detailed critical review by the FDA of the data from the Pfizer trial and a review by a rigorous independent scientific committee, the first vaccine is now ready for administration and the second will likely follow.
This means that as the supply of vaccines increases, they can be rolled out in states and donated to the most at-risk and vulnerable groups. But they cannot receive traditional FDA clearance until additional months of safety and efficacy data can be further examined by the FDA and they clear biologic license approval. complete. There will be no shortcuts that compromise security.
The distribution of vaccines initially in short supply in all 50 states will be extremely complex and difficult. But we have to recognize that our underfunded CDC has succeeded in creating a system that delivers millions of vaccines to children and adults every year in every state across this country.
The system will be stressed, there will be glitches, but there is every reason to believe that all Americans ready to accept Covid-19 vaccines could be vaccinated by the end of the summer.
So far, the data has clearly established that vaccines prevent Covid-19 disease. What we do not yet know to what extent they will prevent transmission and for how long they will protect. Therefore, it is essential that we continue to observe all public health precautions – masks, personal distancing, avoidance of crowds – until at least 60-70% are vaccinated.
Scientists and companies have done their job well. It will now be up to us, the people, to end this devastating epidemic.