Regina Au photo 1
Regina Au photo 1

Opinion: One Biotech Executive’s View on the COVID-19 Vaccine

Why is Lioness talking about the COVID-19 vaccine? Because COVID is a concern for entrepreneurs everywhere. Nothing has had such an impact on business in decades. Now that vaccines are becoming available, we have new business (and personal) concerns. Will you get vaccinated? Will you ask employees to get vaccinated? CAN you ask them to do it before they return to the office?

More than 400,000 people in the US have died from COVID-19; a person is dying every 6 minutes. More than 20 million people have tested positive for COVID-19 and this number continues to grow exponentially. A new UK variant deemed more contagious will create a surge upon the existing surge, potentially overwhelming every hospital in the US.

Questions regarding the safety of the vaccines continue to surface. The vaccines were developed over an incredibly short amount of time, especially when compared to traditional methods. Concerns have stalled many vaccination programs and delayed us in achieving herd immunity. 

Both Pfizer and Moderna have a messenger RNA (mRNA) technology platform to develop their vaccines. Messenger RNA is not new, in fact, research has been done for over two decades. According to Nature,  “A lot went into the mRNA platform that we have today,” says immunologist Akiko Iwasaki at the Yale School of Medicine in New Haven, Connecticut. Iwasaki has worked on nucleic-acid vaccines — those based on lengths of DNA or RNA — for more than two decades. 

The COVID-19 experience will almost certainly change the future of vaccine science, says Dan Barouch, director of the Center for Virology and Vaccine Research at Harvard Medical School in Boston, Massachusetts. Barouch was also interviewed by Nature. “It shows how fast vaccine development can proceed when there is a true global emergency and sufficient resources,” he says. New ways of making vaccines, such as by using messenger RNA (mRNA), have been validated by the COVID-19 response, he adds. “It has shown that the development process can be accelerated substantially without compromising on safety.”

Safety is a Priority

The FDA’s priority is safety and even Emergency Use Approval (EUA) will not compromise this. They may be lenient on efficacy but will always be steadfast on safety, even in a pandemic. While Dr. Fauci has said he would be happy with a vaccine with 50 percent efficacy, Pfizer and Moderna have a 94 percent and 95 percent efficacy respectively. The FDA doesn’t want any backlash if a product is perceived to be unsafe. Public opinion will be quick to turn. “How this could have happened?” “Why are they not doing their job in keeping the public safe?”

Pharma/Biotech companies prioritize safety because their reputations are on the line. These companies are experts in developing and launching safe and efficacious products. If they have a product that is perceived to be unsafe, any subsequent products will not be looked upon favorably. Consumer memories are long and capricious. All people will remember is the one product that was not safe.

The mRNA technology is becoming so attractive that a number of Big Pharma companies are investing in this technology. Sanofi has deals with BioNTech and Translate Bio, CureVac has deals with Sanofi, Eli Lilly, and Boehringer Ingelheim and most recently Bayer. These pharma/biotech companies will only invest in technology that is promising in safety and efficacy.

But what about long-term safety? Of course, no one can predict the long-term effects of a vaccine but there have been numerous vaccines that have been proven to work and prevented people from contracting diseases such as the flu.  We could wait 10 years to see if this new vaccine is safe over the long run, but what is the alternative?  You may not be around in 10 years. The virus does not discriminate. No one knows who will contract the disease, who will exhibit mild symptoms, require hospitalized or die. If you don’t get the vaccine, you are basically gambling on your life and the odds are not in your favor.

By mid-January 2021, more than 20 million people were infected and there were more than 400,000 deaths.  The CDC predicts that the death toll will reach 500,000 soon if it hasn’t already. If I was offered the vaccine today, I wouldn’t hesitate to take it. 

About Regina Au

Regina Au is CEO, New Product Planning/Strategic Planning at BioMarketing Insight with 20+ years experience in the biotechnology, pharmaceutical, medical device, diagnostic and healthcare industries.  She helps companies to maximize the benefits of their technology by conducting the business due diligence early in product development to de-risk the process and increase commercial success.  This ensures that the technology is the right product for the right market in meeting a critical unmet need and that the market opportunity for the product meets the business goals of the company.  She will translate these unmet needs into a marketing target product profile (TPP) with the R&D TPP.  Ms. Au then develops marketing strategies to ensure market access and product adoption. Email Regina at

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