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When will there be a vaccine for the novel coronavirus?

After months of living through the first wave of COVID-19, it’s crucial to take a step back and evaluate what progress has been made for the prevention or treatment.

While there are currently at least 80 pharmaceutical and/or biotech companies working to develop a vaccine, none have completed clinical trial phases or been approved by the Food and Drug Administration (FDA).

With so much research being done on various ingestible medication classes such as antimalarials, antivirals, antihistamines and many others, the vaccine progression and status sometimes may get overlooked. With the national stay-home orders about to expire this month, the government is making vast efforts to have a safe and effective vaccine ready by January 2021.

“Operation Warp Speed” is the name of the project that plans to produce over 300 million doses to be dispersed among the entire country with more than 3.4 million infected.

What we know so far

Since March 2020, only six companies are testing potential vaccines in humans trials. Various advanced technologies are being tested to help break down the COVID-19 spiked molecule including NasoVAX, PCR-based DNA (“Linear DNA”), viral deoptimization, Timer-Tag, I-Cell, AdVac and PER.C6, and saponin-based Matrix-M. Currently leading the charge is mRNA. Messenger RNA (mRNA) is a single-stranded RNA molecule that corresponds to the genetic sequence of a gene and is read by the ribosome in the process of producing a protein. The innovative lipid nanoparticle-encapsulated mRNA-based vaccine works by encoding for a prefusion stabilized form of the spike (S) protein of SARS-coV-2. The maker of this vaccine plans to start a phase three study early this summer to have a Biologics License Application (BLA) approved as early as 2021.

How much protection will we have in the community since so many are infected?

This is known as herd immunity; it occurs when enough people are immune to a particular disease or virus to help prevent further spread. Social and economic activities may not be considered “normal” until herd immunity is achieved. Unfortunately, it may take years (four to twelve years) to develop immunity. A future vaccine will most likely be granted emergency use due to this public health emergency, but this is not the typical process to release a new product for mass volume distribution.

Mass production, distribution of vaccine will not come without challenges

One main concern will be the ability to have enough to cover the population. Companies are making adjustments to have 24-hour, seven-day-a-week production schedules in place to attempt to keep the target date. The second potential issue would be the uncertainty of the need for booster shots. If multiple shots are needed, it could drastically affect the demand on shortages. One area of the human trials is to find the right dose(s) that will lead to permanent immunity. An ideal vaccine candidate will prevent infection in 70-80% of the population, but anything over 50% could be considered effective.

A balancing act

The next six months will be a juggling act to find the balance of re-opening the country, but still use precautions while we wait for the development of a vaccine.

A second wave, predicted to peak along with the 2020-21 influenza season, is certainly a possibility since we are failing to reduce the number of COVID-19 infections.

What we do know is that limiting the number of infections with current control measures now can help lower the number of infections later.  Veradigm works closely with our medication vendor to provide the latest COVID prophylaxis and/or treatment regimens within our software for easy prescribing.

Comments 1

  1. CM 05/27/2020

    Interesting read. I’ve been offered the opportunity to participate in Moderna’s phase 3 trials (mRNA vaccine), assuming phase 2 completes successfully. Now to see how phase 2 shakes out and decide if participating in phase 3 is something I’m comfortable doing. I’d be interested in reading your take as the trials progress.

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