New Pharmaceutical Industry Developments for 2021
The start of this new decade will forever be identified with the coronavirus pandemic, and it has shoved the normally low profile pharmaceutical industry out of the background into the spotlight.
The past year was marked by rapid vaccine development. 2021 will be different, as much of the Pharma industry focuses its energies on mass vaccine production.
Within this pandemic environment, we take a deeper look at the key trends to watch across all of the pharmaceutical industry in 2021.
The Success Of MRNA Coronavirus Vaccines Opens The Door To A Wider Genomic Medicine Revolution
When we first wrote about coronavirus vaccine development a year ago, we shared the skepticism of many health experts who, based on previous experience, believed it would take at least 18 months to develop and deploy a successful vaccine — at the very quickest!
Little did we know at the time that scientists at Moderna had developed a theoretical messenger RNA-based vaccine design in just 48 hours before the US had its first recorded case — and they had a working prototype ready to test on lab animals just 6 weeks after that.
The crash vaccine development programs at Moderna (and fellow mRNA vaccine pioneer Pfizer BioNTech) have accelerated the adoption of mRNA vaccine technology by many years — and the potential for treating other diseases using this technology is great — making this one of our top bellwether trends for 2021.
Speaking to MIT Technology Review, Moderna’s CEO Stéphane Bancel, whose company’s stock has made him a millionaire on paper, points out that the mRNA components can be reprogrammed — just like software. “The way we make mRNA for one vaccine is exactly the same as for another,” he says. “Because mRNA is an information molecule, the difference between our Covid vaccine, Zika vaccine, and the flu vaccine is only the order of the nucleotides.”
In theory, this new technology could allow scientists to develop vaccines and clinical treatments for many of the most stubborn diseases, including sickle-cell anemia, HIV, herpes, infant respiratory virus, liver disease, and malaria.
Coronavirus Vaccines Will Become A Recurring Revenue Stream
The coronavirus vaccine has not been well-controlled in many nations, and unfortunately, Covid-19 has taken advantage of this opportunity to develop new viral strains, which complicate efforts to successfully vaccinate populations in time to achieve herd immunity.
Strain B.1.1.7, which was first detected in the UK, has now spread to America. It’s much more contagious than the original strain, and B.1.1.7 infections are reportedly doubling every 10 days, which means that this UK variant will be the dominant strain in the US sometime in March.
These variants, such as the B.1.315 South African one, can significantly reduce the effectiveness of certain vaccines. The South African government recently halted its rollout of AstraZeneca’s Covid-19 vaccine because it was found to only be 10% effective against B.1.315.
That’s not the only discouraging news. Some of these new variants may also reinfect people who have already had the original version of the coronavirus.
The emergence of these new variants is causing a rethink among public health officials about the strategy for developing herd immunity.
In the future, we may come to view coronavirus vaccination programs as an annual event, much like getting an annual flu shot, where people need to be re-inoculated against whatever variant of the disease is currently circulating among the population.
Albert Bourla, CEO of Pfizer, was recently asked about whether Covid vaccination programs will follow the pattern of annual flu shots. “We do not know yet, but it looks like Covid is here to stay,” says Bourla. “But also, it looks like we have the tools to make Covid like the flu. That means it will not disturb our lives or the economy. We just need to be very vigilant about [tracking new] strains. And we need to be very vigilant about vaccinating people.”
(The good news for Pfizer is that preliminary studies indicate that its vaccine will work against the current generation of virus variants.)
What are the implications for the pharma industry overall?
First, as Bourla suggests, we are going to have to significantly beef up our ability to perform rapid genomic sequencing across the US to detect new variants early.
The second implication is that the nascent Covid vaccine industry will need to transition to an FDA approval process that is modeled after flu vaccines; this approach, known as bridging studies, allows regulators to assess and approve minor changes in a vaccine formulation to account for different virus variants without having to redo massive vaccine trials, which can take many months.
Plans for this are already underway. Both Moderna and Pfizer have indicated that they are ready to alter their mRNA vaccines as needed, and Glaxo Smith Klein (GSK) and CureVac recently inked a $183 million deal to develop a vaccine that addresses multiple variants in one shot.
The financial implications for the pharmaceutical industry may be significant. The revenue model for a recurring vaccine is potentially much more lucrative than one that only needs to be administered one time.
World-Wide Pharma Supply Chain Challenges Through 2022
Our third trend touches on how the pharmaceutical industry is being dragged into national politics as efforts are underway to ramp up vaccine production around the world.