On November 16th Moderna (NASDAQ: MRNA), one week after Pfizer (NYE: PFA), announced 

• The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5% (p <0.0001).
• A secondary endpoint analyzed severe cases of COVID-19 and included 11 severe cases (as defined in the study protocol) in this first interim analysis. All 11 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group.
• The 95 COVID-19 cases included 15 older adults (ages 65+) and 20 participants identifying as being from diverse communities (including 12 Hispanic or LatinX, 4 Black or African Americans, 3 Asian Americans and 1 multiracial).

The results show...

• The study found people who got Moderna’s shot were less likely to develop COVID-19, the disease caused by the novel coronavirus. 

• The drugmaker said the shot was found to be more than 94.5% effective in preventing COVID-19 (PFA 90.0%) .  

Regulators have previously said they would approve a vaccine that had just 50% effectiveness. The MRNA vaccine is different to normal vaccines (but similar to PFA’s vaccine) in that it uses the genetic code of the vaccine rather than any part of the vaccine itself.

The trials

• The trial is still ongoing, and the interim results have not been published in a peer-reviewed medical journal.

MRNA said 11 serious safety concerns had been observed throughout the trial, which enrolled about 30,000 patients, but these all received the placebo (PFA 43,538 and nil). 

However, testing was performed on diverse communities of varying ages whereas (PFA’s was only performed on fit and healthy individuals).

Normal Phase 3 clinical trials on humans involve comparison using double-blind placebos.

MRNA’s was a Phase 3, randomized, stratified, observer-blind, placebo-controlled study – the placebo was 0.9% sodium chloride (normal saline) injection, which meets the criteria of the United States Pharmacopeia (USP) -it is strange how 11 had adverse reactions.

PFA’s was only compared to a control group where the placebo was the meningitis vaccine. 

Production

• The vaccine will not be distributed immediately.
• It still needs to be evaluated by the US Food and Drug Administration.

MRNA is now ramping up production of the vaccine.

Australia doesn’t have a contract with MRNA to produce this vaccine locally.

Australia only has contracts with PFA, University of QLD, Novavax and Astrazenaca.

Storage

• mRNA-1273 remains stable at 2° to 8°C (36° to 46°F), the temperature of a standard home or medical refrigerator, for 30 days.
• Stability testing supports this extension from an earlier estimate of 7 days.
• mRNA-1273 remains stable at -20° C (-4°F) for up to six months, at refrigerated conditions for up to 30 days and at room temperature for up to 12 hours
• This compares to PFA’s drug which requires to be stored at -70° C

Impact upon Aegros ( is same as with Pfizer)

Aegros’s operations comprise the following three business units:

1. Therapeutics: manufacturing and supplying plasma-based therapeutics (Covimmune™);
2. Facilities: building of fractionation facilities in other countries at US$60m per 100,000L facility and A$20m profit per transaction; and
3. Consumables: supply of consumables to the fractionation facilities US$6m pa for each 100,000L processed.

Aegros’s COVID-19 treatment utilising its patented Electro Separation technology (Covimmune™). The treatment, which has been trademarked as ‘Covimmune’, is developed by extracting and concentrating antibodies from the blood of individuals that have recovered from COVID-19.  The blood of individuals that have received a vaccine is equally valid.

Hence, PFA’s CoVID-19 vaccine potentially expands the number of available donors for the supply of plasma to Aegros.   

In addition, Aegros’s treatment can also be of use to those not wishing to receive vaccine for any religious, other moral grounds or allergies.

In the absence of COVID-19 Aegros can resort to its other two highly profitable businesses.  Meantime, vaccines will not eliminate COVID-19

Aegros update

Aegros requires ethics approval before they can commence recruitment of patients to inoculate.

The Human Research Ethics Committee sent Aegros a list of additional questions last Friday. 

It is expected it will take Aegros a week to compile the necessary responses. 

Hence, Aegros are still on track for the first participant to be incoulated in the first week of December.

Moving Forward

If the vaccine cannot reduce infection, hospitalisation or death, then it cannot end the pandemic, which means everyone who takes the vaccine might be doing so in vain. Only mass-testing can be expected to end the pandemic and this is underway outside of vaccine companies.

Until the pandemic ends Aegros can power ahead with its CovImmune™ therapeutics business.