COVID News: Pfizer, AstraZeneca, Lilly, J&J, & More
By

The latest on COVID-19 vaccines/drugs and manufacturing from Pfizer, AstraZeneca, Lilly, J&J, GSK, and Novavax. Highlights below.

Manufacturing and supply of COVID-19 vaccines and drugs
* Pfizer, BioNTech Amend EU COVID-19 Vaccine Supply Pact
* US, EU Provide Update on Joint COVID-19 Initiatives
* AstraZeneca, RQ Bio in Pact for mAbs Against COVID-19
Updates on COVID-19 treatments and vaccines
* FDA OKs Pfizer’s/BioNTech’s COVID-19 Booster to Children 5 through 11
* FDA OKs Lilly’s COVID-19 Drug for Certain Hospitalized Patients
* FDA Limits Use of J&J’s COVID-19 Vaccine
* Novavax Seeks OK for COVID-19 Vaccine in Adolescents
* FDA OKs Shelf-Life Extension of Lilly’s COVID-19 Drug
* FDA Continues To Evaluate Shelf Life of GSK’s COVID-19 Drug


Manufacturing and supply of COVID-19 vaccines and drugs

Pfizer, BioNTech Amend EU COVID-19 Vaccine Supply Pact
Pfizer and BioNTech have reached an agreement with the European Commission (EC) to amend their contractual delivery schedules for the companies’ COVID-19 vaccine.

Doses scheduled for delivery in June 2022 through August 2022 will now be delivered in September 2022 through the fourth quarter 2022. This change of delivery schedule does not impact the full-year commitment of doses to be delivered to European Union member states in 2022.

Source: Pfizer and BioNTech


US, EU Provide Update on Joint COVID-19 Initiatives
The US and the European Union (EU) provided an update earlier this month (May 2022) on their joint initiatives to combat COVID-19, including increasing vaccine manufacturing, supply, and delivery. US President Joe Biden and President of the European Commission Ursula von der Leyen provided an update on key milestones in their partnership, which was announced last September (September 2021).

To strengthen global supply chains and manufacturing of COVID-19 vaccines, a joint EU–US COVID-19 manufacturing and supply chain task force was launched in September 2021.  The task force will extend its activities to provide early warning of supply-chain bottlenecks that could hamper global availability of vaccines and treatments and to coordinate production capabilities for variants and future pandemics, including those in Africa.

With regard to global vaccine supply, the US and EU reported that they have provided more than one billion COVID-19 vaccine doses and are on track to share a total of 1.9 billion doses globally. The governments will work to ensure ongoing deliveries are based on country demand, with a focus on sub-Saharan Africa. The US and EU officials also highlighted the work of Team Europe, a joint effort by the EU, its member states, and EU financial institutions to combine resources to provide COVID-19 vaccines globally, and US Global VAX, a US government initiative. Both the EU and the US are participating in a global effort to reach a goal vaccinating  70% of the population of every country against COVID-19 in 2022. EU and US officials stressed that vaccine equity starts with best-practice donation principles, which includes adequate and transparent planning in cooperation with governments, in-country partners, the Africa Vaccine Acquisition Task Team (an initiative to provide Africa with access to COVID-19 vaccines), the World Health Organization, the COVID-19 Vaccine Delivery Partnership (a partnership aimed at helping countries build absorptive capacity for vaccine deliveries), and others.

Additional goals of the partnership are: (1) research and development for new vaccines, therapeutics, and diagnostics; (2) enhanced EU–US coordination to improve global health security architecture; and (3) preparing for future, pathogen detection and monitoring, joint threat assessment, and response.

Source: White House


AstraZeneca, RQ Bio in Pact for mAbs Against COVID-19
AstraZeneca has entered into a license agreement with RQ Biotechnology (RQ Bio), a newly launched London-based bio/pharmaceutical company focused on developing treatments and preventative therapies based on monoclonal antibodies (mAbs) against SARS-CoV-2, the virus that causes COVID-19.

Under the agreement, RQ Bio has granted AstraZeneca an exclusive global license to develop, manufacture, and commercialize RQ Bio’s existing early-stage mAbs against SARS-CoV-2 and a right of first refusal to take an exclusive license of any additional mAbs against SARS-CoV-2. RQ Bio will receive upfront and milestone payments of up to $157 million and will be eligible to receive single-digit royalties on sales.

The licensing deal was supported by Oxford University Innovation, a wholly owned subsidiary of the University of Oxford that manages the University’s technology transfer and consulting activities.

Source: AstraZeneca and RQ Biotechnology


Updates on COVID-19 treatments and vaccines

FDA OKs Pfizer’s/BioNTech’s COVID-19 Booster to Children 5 through 11
The US Food and Drug Administration (FDA) has amended the emergency use authorization (EUA) for the Pfizer’s/BioNTech’s COVID-19 vaccine to authorize a single booster dose to children aged five through 11 years old. 

The booster dose is given at least five months after the second dose of the two-dose primary series and is the same 10-µg dose of Pfizer’s/BioNTech’s COVID-19 vaccine. To date (as reported on May 17, 2022), more than eight million five- to 11-year-olds in the US have completed a primary series.

Source: US Food and Drug Administration, Pfizer, and BioNTech


FDA OKs Lilly’s COVID-19 Drug for Certain Hospitalized Patients
The US Food and Drug Administration (FDA) has approved a new indication for Olumiant (baricitinib), Eli Lilly and Company’s arthritis drug also authorized for treating COVID-19, for treating COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

The FDA first issued an emergency use authorization (EUA) for Olumiant in combination with remdesivir, Gilead Sciences’ antiviral COVID-19 drug, to treat COVID-19 in hospitalized adults and pediatric patients in November 2020. In July 2021, the FDA revised the EUA to authorize Olumiant as a stand-alone treatment. Olumiant remains under EUA status for hospitalized pediatric patients aged two to less than 18 years of age requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.

Source: Eli Lilly and Company and the US Food and Drug Administration


FDA Limits Use of J&J’s COVID-19 Vaccine
The US Food and Drug Administration (FDA) has limited the authorized use of Johnson & Johnson’s (J&J) COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the J&J COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine.

The FDA has also updated J&J’s US COVID-19 vaccine Fact Sheet to increase awareness about the risk of thrombosis with thrombocytopenia syndrome , a very rare adverse event involving blood clots in combination with low platelet counts.

Source: US Food and Drug Administration and Johnson & Johnson


Novavax Seeks OK for COVID-19 Vaccine in Adolescents
Novavax, a Gaithersburg, Maryland-based vaccine company, has submitted variations in its regulatory filings in Australia and New Zealand to expand provisional approval of Nuvaxovid, its COVID-19 vaccine, to include adolescents aged 12 through 17 years old.

Novavax submitted variations to Australia’s Therapeutic Goods Administration (TGA), the national pharmaceutical regulatory agency in Australia, and to New Zealand’s Medsafe, the medical regulatory body run by the New Zealand Ministry of Health. TGA previously granted provisional registration in individuals 18 years of age and older in January 2022. Medsafe previously granted provisional approval in individuals 18 years of age and older in February 2022.

Separately, Novavax submitted a request for emergency use authorization to Taiwan’s Food and Drug Administration for its COVID-19 vaccine for in individuals aged 18 and over. The vaccine has received conditional authorization in individuals older than 18 years from multiple regulatory agencies worldwide with additional filings currently under review (as reported on May 13, 2022).

Novavax also announced that deliveries of Nuvaxovid continue globally, and the first doses in Singapore arrived in early May (May 2022).

Source: Novavax (Australia/New Zealand), Novavax (Taiwan), and Novavax (Singapore)


FDA OKs Shelf-Life Extension of Lilly COVID-19 Drug
The US Food and Drug Administration (FDA) has authorized an extension to the shelf-life of certain lots of Eli Lilly and Company’s COVID-19 drug, bamlanivimab, from 18 months to 24 months. Bamlanivimab is part of an antibody cocktail, which also includes etesevimab, for treating COVID-19.

Evaluation of future extension of shelf-life for etesevimab is ongoing, and an update on shelf-life extension for etesevimab is planned for November 2022. Therefore, the FDA says that in the interim, all etesevimab vials may be retained until the shelf-life extension evaluation is complete and posted, regardless of the current labeled expiry date or previously provided extension dates.

Source: US Food and Drug Administration and the US Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response


FDA Continues To Evaluate Shelf Life of GSK’s COVID-19 Drug
The US Food and Drug Administration (FDA) and the US Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) continue to evaluate the shelf-life of sotrovimab, a drug for treating adults and adolescents with COVID-19 from GlaxoSmithKline (GSK) and Vir Biotechnology, a San Francisco-based bio/pharmaceutical company.

Due to the high frequency of the Omicron BA.2 variant, sotrovimab is not currently authorized in the US region, as reported by the FDA last month (April 2022). However, the FDA recommends that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to sotrovimab, emerge and become prevalent in the US.

The FDA advises that all sotrovimab vials may be retained until the shelf-life extension evaluation is complete and posted, regardless of the current labeled expiry date or previously provided extension dates. This recommendation applies to all unopened vials of sotrovimab that have been held in accordance with storage conditions detailed in the authorized fact sheet for healthcare providers and the letter of authorization.

Source: US Food and Drug Administration