The first COVID-19 vaccines – products of Pfizer-BioNTech and Moderna have been administered in the United States. Research companies – including Johnson & Johnson, Novavax, and AstraZeneca – are also making incredible progress to bring a vaccine to the public.
We have come this far and quickly because biopharmaceutical research companies are devoting unprecedented time and capital to the effort. This includes shifting focus, staffing, and financial resources from other projects to bring an end to this pandemic as fast as possible.
As we near closer to the finish line, however, the number of U.S. adults willing to take a future COVID-19 vaccine has steadily dropped, according to a recent poll. Many worry the push for the rapid development of a vaccine will lead to a lapse in traditional safety and efficacy safeguards.
These fears are understandable, but ultimately unwarranted. Biopharmaceutical researchers can deliver a safe and effective vaccine faster than ever because of intense industry collaboration and decades of private-sector innovation.
The vaccine development process is designed with safety at top of mind. Promising candidates for COVID-19, or any other infectious disease, are subject to the “gold standard” of scientific testing – randomized, placebo-controlled, and event-based clinical trials – and oversight by independent data safety monitoring boards before reaching patients.
After passing all safety and efficacy bars in the traditional three-stage clinical trial process, vaccines undergo additional studies post approval and licensing to monitor patient wellbeing.
The process from early exploratory research to when patients ultimately receive a vaccine usually takes years. But with COVID-19, researchers already have nearly 200 vaccine candidates in the pipeline – mere months after the virus appeared stateside.
Many Americans are justifiably questioning this timeline. But there are several key reasons why the biopharma industry has mobilized so quickly.
For starters, the industry has leveraged novel technologies to identify promising vaccine candidates faster, which ultimately streamlines development and testing. A few decades ago, scientists were limited in their approach to vaccines, such as relying on injecting a weak version of a virus in the body to build immunity and ward off potentially harmful pathogens in the future.
Today, vaccine developers rely on a slew of new biotech advancements that help identify potential vaccine targets in a flash. This includes innovation in platform technologies such as viral vector, mRNA and DNA vaccines, and protein expression systems. These platforms provide a common foundation for a vaccine that can be quickly leveraged across different vaccine targets.
Thanks to this innovation, researchers aren’t starting from square one for every vaccine attempt. Consider Maryland-based vaccine maker, Novavax. The company deployed the technology they developed to fight SARS and MERS – two coronaviruses – as a starting point for their experimental COVID-19 vaccine, which is currently in clinical trials.
In this way, a COVID-19 vaccine has been decades in the making. There are billions of dollars of private investment and years of hard work that enable biopharmaceutical researchers to pivot to creating a novel vaccine with extraordinary speed.
Moreover, we’ve witnessed unprecedented levels of public-private-sector collaboration.
Consider the development of government guidance outlining critical R&D decisions. Typically, individual companies work with the federal safety regulators to establish specific research and testing parameters for each product. Guidance released by the FDA provides all vaccine developers combating COVID-19 a common baseline for what researchers are going to test, when to test it, scientific standards for safety and effectiveness, and the role of a data and safety monitoring board in the entire process. Thanks to this guidance, vaccine developers have focused their time and energy, on finding cures.
Also consider how biopharmaceutical research companies, with help from the NIH, have leveraged as many existing clinical trial sites as possible to hasten the process of finding enough trial participants. Locating the right number of volunteers as well as the right demographics can be a long and arduous process. With industry and NIH collaboration, researchers could begin clinical testing sooner than usual while still securing participation sizes similar to that of regular-order vaccine trials.
Rest assured: researchers and their government partners are not sacrificing safety for speed in the race for a COVID-19 vaccine.
For further proof, biotech companies leading vaccine development efforts have publicly reaffirmed their commitment to safety, first and foremost, along with the scientific process. Pfizer, Moderna, Johnson & Johnson, Novavax, and others recently pledged to seek approval for products only after demonstrating “safety and efficacy through a Phase 3 clinical study” in accordance with FDA requirements.
Vaccines will help end this pandemic. Americans should feel assured that the COVID-19 vaccine development and approval process has adopted the same scientific rigor and safety standards we’ve come to expect for new therapies.
Michelle McMurry-Heath is a physician scientist and BIO’s third president and CEO. Prior to joining BIO, she led a global regulatory team of 900 people at Johnson & Johnson in the medical device space. Before that she was a senior official in the FDA’s Center for Devices and Regulatory Health, was the top legislative aide for science and health for Sen. Joe Lieberman, and served on President Obama’s science transition team.
Using these vague “policy violations,” Google is now threatening to demonetize us. It’s part of Big Tech’s effort to silence conservative voices.
I will pass, way to much push to get a temporary reprieve from a flu. The experts have not been right yet and the FDA has been wrong before. Wait and watch
She sounds very accomplished, but when you said she was on Obama’s team, sadly, my trust is less than 100% by reflex.
I really don’t care how “safe” or effective it is, quite frankly. For a disease with a 99.6% recovery/survival rate, I’m not going to take it. I’ll keep myself health with a good diet, immune boosting supplements and exercise (at home, of course, since those idiots have closed gyms).
Maybe that’s the view from inside big pharma?
Three words, Sir. Phase three trials.
Racing to develop and deploy vaccines in close to no time at all was exactly the right thing to do. Back when the starting gun was fired we had very limited info about how the pandemic would develop; had we been in very deep doo-doo by now we’d have arguably found the semi-tested vaccines to be lifesavers.
Didn’t happen We got around 0.1% mortality and that almost entirely among the very frail. Furthermore the disease appears to be easy to treat — though your fellows in the industry were pretty successful in hiding that fact. The proper use of vaccines today is those at greatest risk who want to be vaccinated and who are considered likely to survive the vaccine itself, second priority those with the very greatest exposure, generally health workers caring for SARS-CoV-2 patients.
And then some others with unusually great exposure — maybe subway riders, for example.
No reason not to make the vaccine available to others generally who happen to want it.
For the rest, WAIT FOR THE RESULTS OF PHASE THREE, now in progress. And the massive world-wide trial now in progress. Hope that this miracle of modern medicine doesn’t have a whole lot of doctors trying to forget the Hippocratic Oath.