With a call to the public, private, military and government sectors to work towards finding a vaccine to help against COVID-19, some vaccines have made it as far as the second step in the Clinical Development stage.

Moderna, Oxford/AstraZeneca, plus Johnson & Johnson plan to make it into the third step (the one before production, if all goes well) starting in July (Moderna), then in August (Oxford/AstraZeneca) and September (Johnson & Johnson/Jansen.)

Moderna, INC.

Moderna announced on Saturday, May 18, 2020 that their Phase I study of the vaccine, mRNA-1273, was returning positive data.

Stéphane Bancel, Chief Executive Officer at Moderna explained, “With today’s positive interim First step in clinical development data and the positive data in the mouse challenge model, the Moderna team continues to focus on moving as fast as safely possible to start our pivotal Final step of clinical development study in July and, if successful, file a BLA.”

BLA is a Biologics License Application, a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2).

They are keeping an eye towards manufacturing to maximize the number of doses they can produce when the trials are complete.

This would be a RNA vaccine made with an mRNA sequence. That means they use a messenger RNA, which is the molecule that tells your cells what to build.

These vaccines are frequently used to fight novel viruses, like influenza, Ebola, or Zika. They are faster and cheaper to produce than standard vaccines.

Oxford/AstraZeneca

The University of Oxford joined with AstraZeneca to work towards a global development and subsequent distribution of a COVID-19 vaccine.

Pascal Soriot, Chief Executive Officer of AstraZeneca states, “As COVID-19 continues its grip on the world, the need for a vaccine to defeat the virus is urgent.”

AstraZeneca has the capability for global development, manufacturing and distribution, while Oxford has top tier expertise in vaccinology.

US Biomedical Advanced Research and Development Authority (BARDA) gave support of $1 Billion to help with the development, production and delivery of a vaccine.

The vaccine, known as AZD1222, is set to begin Phase II/III trials in around 10,000 adult volunteers, with plans for global distribution by the end of the year being the goal.

The vaccine is scientifically explained as using, “A replication-deficient chimpanzee viral vector based on a weakened version of a common cold (adenovirus) virus that causes infections in chimpanzees and contains the genetic material of SARS-CoV-2 spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack COVID-19 if it later infects the body.”

As of Thursday, June 4, 2020, three-hundred and twenty people were given the vaccine and it seems to be safe and well tolerated with only temporary side effects, such as fever, headache, sore arm, or influenza like symptoms.

Johnson & Johnson through Janssen Pharmaceutical Companies (Janssen)

Johnson &Johnson is a leader in their field making everything from Tylenol® to Baby Lotion, and is a household name throughout the United States.

They own Janssen, a pharmaceutical company, who is also on the path for a COVID-19 vaccine.

Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson and Johnson explained, “We are pleased to have identified a lead vaccine candidate from the constructs we have been working on since January. We are moving on an accelerated timeline toward First step in clinical development human clinical trials at the latest by September 2020 and, supported by the global production capability that we are scaling up in parallel to this testing, we expect a vaccine could be ready for emergency use in early 2021.”

As they have moved forward they identified a vaccine, Ad26.COV2-S, that is moving into the first and second step in clinical development study with one-thousand and forty-five healthy adults in the United States and Belgium.

If the outcome of first step in clinical development is approved, Janssen will be into position to move into final step of clinical development ahead of schedule.

The company has committed to more than one billion doses globally through the course of 2021, assuming the vaccine is safe and effective.

In last week’s edition the way vaccines are made was covered, and check back next week once again for more information on the Covid-19 vaccine trail.