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Pfizer, Moderna Release COVID-19 Vaccine Trial Protocols

Striving to be transparent with the public about the development of their COVID-19 vaccine, Pfizer Inc. and Moderna, Inc. have both released the study protocols for their vaccine trials. AstraZeneca PLC is likely to follow, and others could be coming as well.

Pfizer released the Phase II/III study protocol for BNT162b2 publicly on 17 September, hours after Moderna similarly released the study protocol for its Phase III vaccine trial. The study protocols detail the design of the trials, including the metrics for measuring efficacy and safety and how many cases of COVID-19 will need to be accrued to trigger interim analyses.

One of the big questions is around the timing for when reliable data could be available. Pfizer has said it will have data available in October and that it could receive an emergency use authorization shortly after, but some public health experts are skeptical the timeline is achievable. The trial has already reached almost the full original enrollment of 30,000 patients, though the company recently expanded the trial to 44,000. (Also see "Coronavirus Update: Rapid Restart For AZ’s Vaccine Trial, Pfizer Upsizes Its Phase III" - Scrip, 14 Sep, 2020.) 

The protocol makes clear that it could take six months to accrue the 164 cases of infection that is the trigger for the final efficacy analysis, based on the assumption of a 1.3% per year incidence in the placebo group, but that the trial could advance much faster if the attack rate is much higher, enabling the study's primary endpoint to be evaluated much sooner.

Under Pfizer’s trial design, the first interim assessment is triggered after 32 COVID-19 cases are accrued, with success criteria set at 76.9% efficacy. The next look is after 62 cases accrue with success criteria set at 68.1%. A third look is at 92 cases with 62.7% efficacy. A fourth assessment is at 120 cases with 58.8% efficacy threshold and the final look is at 164 cases, with a successful efficacy threshold at 52.3%.

The US Food and Drug Administration has guided to a minimum of 50% efficacy for a vaccine to be considered successful, but during Pfizer's R&D Day on 15 September worldwide president-R&D Mikael Dolsten said he believed the vaccine efficacy would be 60% or more.

Moderna is using a similar 60% efficacy target. It is planning two interim analyses (IA), the first when approximately 53 cases (35% of total cases) have accumulated and the second after 106 cases (70% of total cases). The protocol says the primary objective of the analyses is for early detection of reliable evidence that vaccine effectiveness is about 30%, although it states “there is no intention to stop the study early if the efficacy has been demonstrated at any of the IAs.”

The primary analysis will be performed when approximately 151 COVID-19 cases (100% of total) have been observed in the study. The protocol says that a total of 151 COVID-19 cases will provide 90% power to detect 60% vaccine effectiveness. However, during a 17 September R&D day, Moderna senior VP-infectious disease development Jacqueline Miller said that is conservative and the vaccine effectiveness rate could be higher. (Also see "Pfizer Appears Slightly Ahead Of Moderna In COVID-19 Vaccine Race" - Pink Sheet, 17 Sep, 2020.)

Moderna’s study began on 27 July and has enrolled 25,296 participants, with nearly 10,000 having already received a second dose. The company is predicting it could get an EUA by year-end. 

Friendly Pharma: Amgen And Lilly Team Up In COVID-19 Manufacturing Pact

Amgen, Inc. will help Eli Lilly and Company scale up manufacturing capacity for its potential COVID-19 antibody therapies under an agreement announced on 17 September, in another sign of how industry is collaborating to help solve the global health crisis.

Together, the companies said they would be able to produce many millions of doses of a treatment in 2021. Lilly announced Phase II data from a trial testing its neutralizing antibody LY-CoV555 one day earlier, showing a positive impact on clearing post treatment and a reduction in the risk of hospitalization. The data from the interim analysis are very early, however, and some analysts said it was inconclusive. (Also see "Lilly Claims Proof Of Concept For Neutralizing Antibodies In COVID-19 Therapy" - Scrip, 16 Sep, 2020.) That trial, BLAZE-1, is continuing with a planned enrollment of 800 patients receiving LY-CoV555 and a second candidate, LY-CoV016.

No terms or financials were disclosed for the Lilly/Amgen supply agreement. Amgen said it is eager to leverage the company's deep technical expertise in antibody development and complex biologic manufacturing to partner with Lilly.

BioNTech Acquires GMP Manufacturing Site From Novartis

Partnered with Pfizer Inc. on COVID-19 vaccine candidate BNT162, BioNTech SE said on 17 September that it will acquire a GMP manufacturing site in Marburg, Germany, from Novartis AG that will give it the capacity to produce an addition 750 million doses of the vaccine per year, or about 60 million per month. The Marburg facility becomes BioNTech’s third in Germany slated for global production of the vaccine if approved by regulators.

The Behringwerke facility, established in 1904, is expected to be ready to produce the vaccine in early 2021, BioNTech said. The German firm is also keeping the facility’s approximately 300 staff in place for rapid transition to production of BNT162 once the deal closes, it said. That transition will be aided by the site’s experienced team and history working with biotechnology drug substance and drug product manufacturing equipment, the company added.

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