On Sunday, the director of the Centers for Disease Control and Prevention accepted the FDA recommendation for the emergency use of the vaccine for those 16 years and older. After many months of growing death tolls, overwhelmed hospitals, lockdown fatigue and economic strife, this is a momentous moment.
The development of novel vaccines against a novel virus in less than a year is an astonishing scientific achievement. From the time the genome sequence of the Covid-19 virus was shared by Chinese scientists in January, biotech and pharma companies immediately began to make candidate vaccines. Vaccine trials commenced soon after and now, in less than a calendar year, the US has authorized a vaccine, with another from Moderna, likely soon to follow.
Previously, the most rapid development for any new vaccine was for mumps, which took four years; most require more than a decade. The speed of the development and testing of the Pfizer/BioNTech vaccine and the name of the project, Operation Warp Speed, have created concern among some who worry about whether we can really know if the vaccines are safe and effective so quickly.
I believe the answer is yes -- for two reasons: the independent scientific reviews were rigorous, and the race for Covid-19 vaccines has been a longer one than people think --- more like a marathon than a sprint.
The new vaccines could not have been developed without a huge amount of planning and research even before this new coronavirus was known to exist. If we were to try and pinpoint a starting point, perhaps it would be 9/11 and the anthrax attacks in 2001.
A US National Academy of Sciences report in 2002 revealed how vulnerable the US was to both terrorist attacks and pandemics. Because the most likely pandemic threat was a new strain of influenza, in 2005 and 2006 the government developed the National Pandemic Influenza Plan, upgraded over the next decade, with a detailed strategy for how to respond when any new pandemic threat, due to flu or any virus, was on the horizon.
Regrettably, the plan appears to have been ignored by the current administration and the team responsible for pandemic preparation, established by the Obama administration in 2015, was disbanded in 2018.
However, at a scientific level, new possibilities of DNA technology revealed that it is feasible to bypass the usual slow processes of developing vaccines, starting with growing it in huge amounts, purifying and testing it, which takes a long time. What modern genetics made possible is going directly from the genome sequence to predicting the components of the virus that are critical to protection and very quickly producing vaccines that contain the target genes or proteins.
The key mRNA technology was developed in the 1990s by Katalin Karikó, who was then working at the University of Pennsylvania. Biotech companies, which first saw potential in the new mRNA technology to treat cancer or rare diseases, soon realized after disease outbreaks such as the H1N1 influenza that they could to create platforms in which genes for any virus could be plugged in that would rapidly generate vaccine candidates.
Their work was bolstered by an important but little-known agency, the Biomedical Advanced Research and Development Authority (BARDA), created in 2006 to prepare and stockpile vaccines against bioterrorist agents, smallpox and anthrax.
BARDA seeks to support the advancement of medical innovation, including new vaccines for emerging virus, and has funded companies developing these new platforms in early stages to accelerate the process.
Before Covid19 was known, BARDA had a hand in funding mRNA vaccines against viruses like influenza, Zika, and respiratory syncytial virus (RSV) though no mRNA vaccine made it to FDA approval.
Then Covid-19 hit. Based on knowledge of the SARS-associated coronavirus, scientists guessed the key Covid-19 protein to be targeted by vaccines and, using genetic engineering, plugged the key genes into their new platforms and showed they were safe in animals and effective at preventing disease. Thus, the planning for new Covid-19 vaccines occurred long before the virus was known to exist and the technical knowledge of the platforms paid off to enable creation of vaccines in record time.
Even prior to 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 hedge their bets on which would work best. And with those advance purchase agreements, the companies could scale up production.
While the science moved more quickly than ever before, the requirements for FDA emergency use authorization remained as rigorous as for any prior approved vaccine. We know that almost all vaccines produce minor vaccination reactions of sore arm, fatigue, fever in some people that disappears in a day or two, and initial vaccinations in the UK revealed that only very few individuals with a history of allergic reactions had more serious vaccine reaction.
Even more promising, Pfizer and Moderna each reported their vaccine to be about 95% effective in preventing Covid-19 disease during clinical trials.
Finally, after a detailed FDA critical review of the Pfizer trial data and review by a tough independent scientific committee, the first vaccine is now ready to be administered, and the second is likely to follow.
That means as the supply of vaccines expands, they can be rolled out to the states and given to the highest risk and most vulnerable groups. But they cannot receive traditional FDA licensure until additional months of safety and efficacy data can be further reviewed by the FDA and they authorize a full Biological License Approval. There will be no shortcuts that compromise safety.
Distribution of vaccines initially in short supply to all 50 states will be hugely complex and challenging. But we have to recognize that our underfunded CDC has successfully created a system that provides millions of vaccines to children and adults in every state in this country each year.
The system will be stressed, there will be glitches, but there is every reason to believe that all Americans willing to accept Covid-19 vaccines could be vaccinated by the end of summer.
The data so far have clearly established that the vaccines prevent Covid-19 disease. What we don't yet know to what extent they will prevent transmission and for how long they will protect. Consequently, it is essential that we continue to observe all public health precautions -- masks, personal distancing, avoiding crowds --- until about at least 60-70% are vaccinated.
The scientists and the companies have done their work well. It will now be up to us, the people, to bring this devastating epidemic to an end.
"Opinion" - Google News
December 15, 2020 at 07:35AM
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Why the astonishing vaccine rollout broke the speed record - CNN
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