Drug manufacturers are under immense pressure to develop the COVID-19 vaccine. Now, they think that they can master a process that typically takes years by producing a vaccine in months.

These companies have already received millions of dollars in funding to scale up manufacturing capacity. But many in the medical community are worried about this type of guarantee.

Challenges ahead

While the news of early successes in vaccine trials has given us hope, COVID-19 vaccine developers face the biggest challenge of their lives. Developing the vaccine in record time and distributing it to the masses amidst quarantines and global travel restrictions will be tough.

Parameters like inventing new kinds of vials and syringes to administer billions of doses, avoiding hurdles in an untested supply chain, and managing extreme storage conditions have to be considered. But if companies can overcome these challenges, pharma manufacturers will be successful in pulling off the most significant medical manufacturing feat in history.

Some experts say that the first phase of production may vaccinate 60% of the world’s population.

Inherent risks

Since vaccines have never been developed at this scale before, filling capacity could be the main limiting factor. Companies and governments are scaling up their machinery to address these critical shortages. This unprecedented scale of manufacturing also means that scientists need to find out whether a vaccine works fast so that production in bulk can begin immediately.

There is also a risk that most coronavirus vaccines under development may fail. While stopping the spread of the COVID-19 virus is imperative, manufacturers are risking millions for a yet-untested vaccine. They are scrambling to get their hands on any available capacity and signing up with multiple manufacturing partners across the globe.

Efforts by the key players

  • Emergent is working on four vaccines in parallel. It is experimenting by making it easier to switch from one vaccine to another with single-use disposable bioreactor equipment that features plastic bags rather than stainless steel fermentation equipment.
  • Moderna is experimenting on new ways to mitigate the extreme cold storage demands of its vaccines.
  • SiO2 Materials Science is working on producing shatterproof vials that can resist super-cold temperatures.
  • Johnson & Johnson is dealing with travel restrictions to send its vaccine experts to oversee the launch of production sites.
  • Catalent is focusing on high-speed production of vial-filling and packaging services to handle millions of doses.
  • Pfizer and BioNTech plan to start Phase 3 testing so that they can produce up to 100 million doses by the end of 2020 and 1.2 billion doses by 2021 for global distribution.
  • Novavax's vaccine combines its proprietary Matrix-M adjuvant with an antigen generated from the virus' spike protein. The early data results will help scientists determine the safety, immunity, and disease reduction to move on to the next phase.
  • AstraZeneca announced that it could produce up to 2 billion doses of AZD1222, the University of Oxford's adenovirus-based COVID-19 shot. It also plans to provide 1 billion doses of the vaccine to low- and middle-income countries.

The U.S. government has invested billions into the Warp Speed initiative to kickstart active COVID-19 vaccine production. Multiple vaccine makers are working at getting legal and administrative approval and begin production with federal backing. The government hopes to make a selection and helps start the production within the next six weeks.

Cautiously optimistic

Vaccine manufacturing is an inherently risky venture. A manufacturing facility is set up only when the clinical data is proven to be safe and effective.

Despite the enormous financial risks stated by experts, finding a vaccine provides hope for the world.

If any of these efforts are successful, it will halt the spread of the deadly virus, which has killed over 650,000 people worldwide and sickened more than 16 million. Economies can reopen, and work and school can resume. Individuals concerned that this race to produce vaccines will upend the traditional drug development process have only to look at the rushing numbers again to see why we need this speedy process.