After dealing with the crippling effects of the coronavirus pandemic for most of 2020, the entire world is waiting for a vaccine that would move the world forward, enable better healthcare, and ensure recovery. However, the road to a cure for COVID-19 will not be easy; aside from scaling up production and distribution, manufacturers must decide which populations should get it first and what people or governments should pay for it.
The Trump Administration, meanwhile, has pressured the U.S. Food and Drug Administration to approve vaccines quickly and establish distribution sites in time for November. It has prompted observers to speculate that this is politically motivated since the administration’s deadline is just days short of the U.S. presidential elections.
Although the FDA has agreed to expedite the approval, healthcare industry experts emphasize that no vaccine is likely to clear before Election Day. The earliest possible date of release, according to them, would be mid-2021. Here is a progress report of four prominent vaccine trials.
Novavax’s NVX-CoV2373
Novavax, a biotechnology company in Gaithersburg, Maryland, announced last September 24 that it is launching its phase three trial in the United Kingdom. It will evaluate the vaccine’s efficacy in up to 10,000 participants, including people with underlying conditions. The company is also pursuing a substudy involving up to 400 participants, which would help determine if NVX-CoV2373 is safe to administer together with the seasonal flu vaccine.
The company has bioengineered the spike proteins of SARS-CoV-2, which helps the virus invade cells. The company injects the vaccine candidate into a nanoparticle carrying this protein and a proprietary compound, one that elicits an immune response.
Johnson & Johnson’s JNJ-78436735
One of the biggest names in the healthcare industry, New Jersey-based Johnson & Johnson’s announced on September 23 that they’re launching a phase three ENSEMBLE trial evaluating JNJ-78436735. It will involve up to 60,000 adults in different countries, including older populations and immunocompromised individuals.
Johnson & Johnson’s vaccine introduces DNA from SARS-CoV-2 into a genetically modified adenovirus that cannot replicate in the body. JNJ-78436735 builds on the technology used in developing a vaccine for Ebola and candidates for HIV and Zika.
Moderna Therapeutics’ mRNA-1273
Moderna is a Massachusetts-based biotech company working with the National Institutes of Health. On July 27, the company announced that it started with the third phase of clinical trials, testing the vaccine in 30,000 U.S. participants. Moderna aims to deliver at least 500 million doses per year, beginning in 2021.
This vaccine relies on injecting the candidate with genetic material from the virus, creating proteins that mimic SARS-CoV-2 and training the immune system to recognize it. If cleared, it will be the first mRNA-based drug approved for human use.
Pfizer’s BNT162b2
New York-based Pfizer is collaborating with German biotech company BioNTech on an mRNA vaccine as well. BNT162b2 draws from the German company’s technology, which the company used in experimental cancer vaccines. Pfizer and BioNTech combine phases two and three of their trials, involving 44,000 people in multiple countries. By the end of 2021, they aim to have supplied 1.3 billion doses worldwide.
Conclusion
Many vaccines are currently in phase three or four of developments, which is also the stage at which regular studies stall. Since the world urgently needs this vaccine, many developers resort to compressing the clinical trial phases for SARS-CoV-2 and running the phases simultaneously. For now, the rest of the world can just wait for more news about these trials.
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