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After Rumors Of Shortcut To Market, AZ Pledges To ‘Follow Science’ In Vaccine Trials

AstraZeneca PLC has launched its global Phase III trial of its COVID-19 vaccine candidate, and has addressed rumors that the US Food and Drug Administration could grant it an emergency use authorization (EUA) before this trial is complete.

Announcing the start of the trials recruiting up to 30,000 people in the US, the company pledged on 31 August that it would not cut corners and instead “follow the science” and “put patients first”.

The statement does not directly address suggestions from President Trump that a vaccine could be approved before US election day on 3 November – as well as reports identifying AstraZeneca and the University of Oxford’s vaccine candidate as the most likely. These rumors were based on the fact that Oxford has already conducted its own trial of 10,000 subjects in the UK, making the candidate, named AZD1222, the most advanced outside Russia and China. 

However remarks made by chief executive Pascal Soriot suggested that, if there had been discussions with the US government, the company will continue with its Phase III trials as planned.

The announcement also comes after growing concerns about the independence of the FDA, and fears that a hasty approval of a vaccine without full safety or efficacy data could be counterproductive in the fight against the pandemic. (Also see "FDA Sidelines Chief Spokesperson As It Grapples With Fallout From COVID-19 Plasma Authorization" - Pink Sheet, 30 Aug, 2020.)

AstraZeneca Soirot Pascal

ASTRAZENECA'S PASCAL SORIOT

“In recent weeks we have seen an increasing number of questions around the safety and availability of vaccines to fight this terrible COVID-19 pandemic and I want to reiterate my commitment that we are putting science and the interest of society at the heart of our work," said Soriot.

The remarks were made in a statement separate from the trial launch announcement, and pledged that the company would "adhere to the highest scientific and clinical standards, making the safety and efficacy of the vaccine of paramount importance." It also promised that the company’s submissions for market authorization "will meet the stringent requirements established by regulators everywhere around the world."

Soriot added: "We are moving quickly but without cutting corners, and regulators have clear and stringent efficacy and safety standards for the approval of any new medicine, and that includes this potential COVD-19 vaccine. We will remain true to our values as we continue our efforts to bring this vaccine broadly and equitably to billions of people around world.”

AstraZeneca's statement is unlikely to be the last word on the subject, however, and President Trump is expected to maintain pressure on the FDA and companies to deliver a vaccine rapidly in the coming weeks.

The two other frontrunners Pfizer Inc./BioNTech SE and Moderna, Inc. are both well advanced into their US-based Phase III trial programs, with Pfizer apparently still on track to be able to file with the US regulator in October. Moderna has forecast a potential filing and approval in time for US Thanksgiving in late November, but its CEO Stephane Bancel this could come earlier if sufficient data was produced by its pivotal trial.

AstraZeneca's Phase III Protocol

To reassure the public and scientific community, full details of AZ's trial protocol are now available. AstraZeneca's US Phase III trials are to be funded by the Biomedical Advanced Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases and are part of the Operation Warp Speed program.

The US trial, D8110C00001, will take the number enrolled in all trials worldwide for the adenovirus vaccine to 50,000 when added to the ongoing late-stage studies in the UK, Brazil and South Africa and those planned in Japan and Russia.

The double-blind trial at approximately 100 centers both in and outside the US will enroll adults aged 18 years or over from diverse racial, ethnic and geographic groups who are healthy or have stable underlying chronic medical conditions, including those living with HIV, and who are at increased risk of infection from the SARS-CoV-2 virus. 

Participants will be randomized in a 2:1 ratio to receive two intramuscular doses of either 5 x1010 viral particles of AZD1222 or saline placebo four weeks apart, on day one and 29. Randomization will be stratified by age (≥ 18 to < 65 years, and ≥ 65 years), with at least 25% of participants to be enrolled in the older age range.

While efficacy and safety will be assessed in all participants, local and systemic reactions and immune responses will be assessed in 3,000. Centers outside the US will be included based on predicted virus transmission rates and sites in Peru and Chile plan to initiate recruitment shortly, the company said.

AstraZeneca's partners at Oxford university had suggested the vaccine could be approved as early as September, based on their UK-based trial, but this looks increasingly unlikely. The pharma company has been unwilling to forecast its own date, but has indicated that filing and approval would be possible before the end of 2020. As with rival studies, this will depend on the rate of infection within communities where the trials are conducted. 

Interim results from the ongoing Phase I/II COV001 trial with AZD1222 published in July showed AZD1222 was tolerated and generated robust immune responses, although the neutralizing antibody response appeared less strong than its rivals and a two-dose regimen was optimum. (Also see "Solid Phase I Results For AstraZeneca COVID-19 Vaccine, But Two Doses Needed To Hit Efficacy Goal" - Scrip, 20 Jul, 2020.)

In the meantime, the UK-based multinational also reiterated in its statement plans to make the vaccine globally available “in a fair and equitable manner as rapidly as possible”. 

Moderna Confirms Japan Vaccine Supply Discussions

Moderna, Inc. has confirmed it is in discussions with Japan’s Ministry of Health, Labour and Welfare over the potential purchase of 40 million or more doses of mRNA-1273, the US company’s vaccine candidate against COVID-19.

Under any final agreement, and assuming a local approval, the vaccine would be supplied by Moderna and distributed in Japan by Takeda Pharmaceutical Company Limited., beginning in the first half of 2021. The talks, announced by health minister Kato Katsunobu on 28 August, form part of Japan’s stated effort to provide a safe and effective vaccine to the public as soon as possible.

Takeda has already entered into an alliance with Novavax, Inc. for the clinical development, manufacturing and commercialization of NVX-CoV2373, Novavax’s COVID-19 vaccine candidate, in Japan. This is made using the US firm’s recombinant protein nanoparticle technology and saponin-based Matrix‑M adjuvant.

Takeda will manufacture the antigen final product and be responsible for a regulatory submission, plus distribution. (Also see "Coronavirus Update: Japan Makes Moves On Vaccine Manufacturing" - Scrip, 11 Aug, 2020.)

The ministry is also finalizing an agreement for the supply of 120 million doses of Pfizer Inc. and partner BioNTech SE’s BNT162 mRNA-based vaccine candidate, beginning in the first half of 2021. (Also see "Coronavirus Update: Russia Plans First Vaccinations In October" - Scrip, 3 Aug, 2020.)

The Japanese government has in addition been in negotiations with AstraZeneca PLC for at least 120 million doses of the UK’s company’s AZD1222 vaccine, being developed with the University of Oxford.

Beximco Allys With Serum Institute For COVID-19 Vaccine

Serum Institute of India Pvt. Ltd. (SII) and Beximco Pharmaceuticals Ltd. have entered into an in-principle agreement to cooperate on progressing a COVID-19 vaccine, for which Beximco will be the exclusive supplier in Bangladesh.

SII, the world’s largest vaccine producer, has partnered with AstraZeneca PLC/Oxford University for supply of their potential COVID-19 vaccine, AZD1222. The Indian firm also has a deal with Novavax, Inc. for its recombinant COVID-19 vaccine candidate NVX-CoV2373, in addition to a collaboration with the biotechnology firm Codagenix Inc. to co-develop a live-attenuated vaccine against the coronavirus. (Also see "Novavax-Serum Institute Seal Win-Win Deal For COVID-19 Vaccine" - Scrip, 6 Aug, 2020.)

Beximco's chief operating officer Rabbur Reza told Scrip that the proposed alliance includes all three vaccines Serum Institute is working on. The Bangladesh firm has distribution experience for other cold-chain products, though not specifically with vaccines.

Under the terms of the proposed deal, Beximco expects to make a financial contribution to advance the development of the vaccine which will be “adjusted” based on the vaccine price. 

On the broad ballpark pricing number that Beximco expects to factor in for its proposed investment in the collaboration with Serum, Reza said only that “price is volume dependent and we are working on this.” Earlier this year Serum indicated that it expects to price the COVID-19 vaccine from Oxford University and AstraZeneca at under INR1,000 ($13.60) per shot. 

In early August, the Bill & Melinda Gates Foundation said that it would provide at-risk funding of $150m to Gavi to support at-risk manufacturing by Serum of the candidate vaccines from AstraZeneca and Novavax. Serum, at the time, set a ceiling price of $3 per dose for the vaccines that will be made available to the 92 countries included in Gavi’s COVAX Advance Market Commitment (AMC). If successful, AstraZeneca’s candidate vaccine will be available to 57 Gavi-eligible countries while Novavax’s candidate will be provided to all 92 countries supported by the AMC. (Also see "Coronavirus Update: Japan Makes Moves On Vaccine Manufacturing" - Scrip, 11 Aug, 2020.)

Under the deal with Beximco, SII will prioritize Bangladesh as “one of the first countries” to receive an agreed quantity of doses once the vaccine receives all necessary regulatory approvals. 

Beximco will buy some quantity for the private pay market in Bangladesh. “However, we are also in communication with the Bangladesh Government to determine their requirements. We will act as a facilitator for the government,” Reza explained. Beximco will help secure the requirements of the Bangladesh government by offering the opportunity for it to reserve the desired quantities for priority supply at prices to be agreed between the Government and SII.  

The number of doses to be provided to Bangladesh on a priority basis and Beximco’s investment amount will be dependent on regulatory approvals, Serum’s production capacity and earlier commitments to other countries, it added.

Beximco already has a portfolio of repurposed COVID-19 treatments on the market. The company had earlier introduced what it said was the world’s first generic version of the antiviral remdesivir (branded Bemsivir). (Also see "Coronavirus Update: AZ Gets $1bn From US, Secures Capacity For One Billion Vaccine Doses" - Scrip, 21 May, 2020.) (Also see "Gilead Remdesivir Production: Partnering, Licensing Concerns And Beximco’s Plans" - Scrip, 6 May, 2020.) 

It has also launched another antiviral, favipiravir (under the brand name Viraflu), the repurposed antimalarial hydroxychlorquine (sold as Kovicin) and the anti-parasitic drug ivermectin (Ivera) as potential treatments for COVID-19. COO Reza said that the firm is also exporting remdesivir and favipiravir to various markets.

Russia Nod For Chong Kun Dang's Nafamostat Trial

South Korea’s Chong Kun Dang Pharmaceutical Corp. has received IND approval from Russia’s drug authorities to begin a Phase II study in COVID-19 with Nafabeltan (nafamostat mesilate).

The drug, which is currently used as a blood coagulant and acute pancreatitis treatment, is undergoing studies globally by multiple companies for potential use in the disease. Chong Kun Dang also recently received IND approval from South Korea’s drug ministry to begin a Phase II study.

The Russian study will be conducted in 100 severe COVID-19 pneumonia patients and will involve administration of nafamostat for about 10 days to confirm therapeutic efficacy; results are expected to be available late this year. If the trials are successful, the firm plans to apply for emergency approval in the setting both at home and abroad.

Among the thousands of drugs being tested by the company with the Institut Pasteur Korea, nafamostat showed the most potent antiviral efficacy against SARS-CoV-2. In June, Chong Kun Dang and the institute reached a co-research pact to develop the drug in the indication.

Chong Kun Dang is also planning to expand the trial program to other countries using Institut Pasteur’s global network.

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