Another announcement from Pfizer Canada and BioNTech was made regarding the initiation of a rolling submission to Health Canada for BNT162b2, the lead candidate from the companies’ vaccine development program against COVID-19. We learned on October 9, 2020 that the rolling submission has been accepted under the Minister of Health’s Interim Order allowing the companies to submit safety and efficacy data and information as they become available.

The rolling review allows Health Canada to start its review right away, as information continues to come in to accelerate the overall review process. Health Canada will not make a decision on whether to authorize any vaccine being considered under rolling review until it has received the necessary evidence to support its safety, efficacy and quality.

Following the authorization of a vaccine submission Health Canada will publish the evidence it reviewed in making its decision, for transparency purposes. The BNT162b2 vaccine candidate is based on BioNTech’s proprietary mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities.

It encodes an optimized SARS-CoV-2 (the virus that causes COVID-19) full-length spike glycoprotein (S), a target of virus-neutralizing antibodies.

The vaccine candidate is currently being evaluated in an ongoing global Phase 3 study at more than 120 clinical sites worldwide. The trial, to date, has enrolled approximately 37,000 participants with more than 28,000 having received their second vaccination.

Important to note is that Pfizer has received FDA approval to enroll adolescents as young as age 12 in COVID-19 vaccine trials to determine the safety and efficacy of the vaccines in this age group. Earlier in the month, Sara Goza, president of the American Academy of Pediatrics, sent a letter to Alex Azar, secretary of the Health and Human Services, and Stephan Hahn, commissioner of the FDA, stating that, “children must be included in vaccine trials to best understand any potential unique immune responses and/or unique safety concerns.”

Many now believe that the Pfizer/BioNTech vaccine will be the first to be used in the clinic against COVID-19.

Both Pfizer and BioNTech stocks are outperforming with BioNTech stock skyrocketing.  

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Moderna

Moderna (MRNA) received written confirmation from the European Medicines Agency (EMA) that its COVID -19 mRNA-1273 vaccine candidate is eligible for submission of an application for a European Union Marketing Authorization under the Agency’s centralized procedure.

The confirmation of eligibility was given in response to the submission of a letter of intent enabling Moderna to evaluate the opportunity for submitting a Marketing Authorization Application (MAA) for mRNA-1273 with the EMA.

This submission has been the outcome of positive results from a preclinical viral challenge study and the positive interim analysis of the Phase 1 study of mRNA-1273 in healthy adults (ages 18-55 years) and other adults (ages 56-70 and 71+) that were published in the New England Journal of Medicine.

Moderna appreciates the EMA’s effective response to this serious public health emergency by establishing a Fast-Track framework which includes: rapid scientific advice, rolling review and accelerated assessment.

Moderna is working with its strategic manufacturing partners, Lonza of Switzerland and ROVI of Spain, for the manufacturing of the vaccine outside of the United States. This is a dedicated supply chain to support Europe and countries other than the United States that enter into purchase agreements with Moderna.

Phase 1 interim analysis demonstrated that Moderna’s vaccine, mRNA-1273, was generally well-tolerated across all age groups and induced rapid and strong immune responses against SARS-CoV-2 in the 18-55 age group.

Neutralizing antibody titers were observed in 100% of evaluated participants and at the 100 µg dose level selected for Phase 3, the geometric mean titers were above those seen in convalescent sera.

The mRNA-1273 vaccine has also induced consistently high levels of pseudo-virus neutralization antibody titers in all participants in the 56-70 age group.

Additionally, vaccination with mRNA-1273 elicited Th1-biased CD4 T cell responses in all age groups. 

Moderna’s mRNA-1273 vaccine is in Phase 3 randomized, 1:1 placebo-controlled trial of 30,000 participants at the 100 µg dose level in the U.S. As of October 9, 2020, the Phase 3 study has enrolled approximately 28,618 participants with over 22,194 having received their second vaccination.  

Clinical Results demonstrate that Moderna’s proprietary vaccine technology has been generally well-tolerated and can elicit durable immune responses to viral antigens. Based on clinical experience across Phase 1 studies, the company designated prophylactic vaccines as a core modality and is working to accelerate the development of its vaccine pipeline.

Prohost Observations 

This is good news from both groups. It’s also encouraging for Moderna’s vaccines’ pipeline, which is based on the use of mRNA created and developed by the firm.

BioNTech stock is outperforming now as it is being considered the first to cross the finish line towards an Authorization Emergency Approval. 

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