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Product Development

COVID roundup: BioNTech-Pfizer vaccine protects adolescents; plus AZ, GSK-Novavax and Amazon

Apr 1, 2021 | 12:36 AM GMT

BioNTech SE (NASDAQ:BNTX) and Pfizer Inc. (NYSE:PFE) plan to request Comirnaty (BNT162b2) emergency use authorization amendments from FDA and EMA to include adolescents based on Phase III data showing no COVID-19 cases in subjects ages 12-15 vs. 18 cases for placebo. The study, which randomized 2,260 volunteers 1:1 vaccine to placebo, also observed mean neutralization titers in the adolescents of 1,239.5 one month after booster shots, which exceeded the levels measured in an earlier analysis in volunteers ages 16-25 (705.1).

The partners concurrently announced they have begun dosing volunteers in the first pediatric age group, ages 5-11, in a Phase I/II/III study that will also have cohorts ages 6 months-2 years and 2-5 years.

Age restriction for AZ vaccine
Canada’s National Advisory Committee on Immunization (NACI) on Monday recommended against immunization of individuals under age 55 with Vaxzevria (AZD1222) while a vaccine-induced prothrombotic immune thrombocytopenia (VIPIT) safety signal is investigated. 

On Tuesday, multiple media outlets said Germany’s regulators had limited use of the adenoviral vector vaccine from AstraZeneca plc (LSE:AZN; NASDAQ:AZN) and the University of Oxford because of thrombotic events. In a statement emailed to BioCentury, an AZ spokesperson said, “We respect the decision taken by STIKO in their advisory capacity for use of vaccines in Germany.”

The pharma added that it is continuing to “analyze its database on tens of millions of records for” Vaxzevria to determine whether thrombocytopenia-associated blood clots occur more frequently than “would be expected naturally in a population of millions of people” and the AZ is continuing to work with German authorities.

The AZ representative pointed to statements published this week by EMA and MHRA that reaffirmed the vaccine’s risk-benefit profile, adding, “Investigations by both the MHRA and EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) were not able to establish a causal relationship between the vaccine and clotting events” but that the committee could not rule out a possible link, which requires further investigation.

EMA’s safety update, which included conclusions from a March 29 ad hoc PRAC meeting, said the reported thromboembolic cases occurred within 14 days of vaccination and were “mostly in people under 55 years of age, the majority of whom were women” and observed a higher event rate in vaccinated individuals than the general population.

AZ said it is “working closely with Health Canada conducting a detailed assessment of the benefits and risks of the vaccine by age and sex in the Canadian context.” 

GSK to support Novavax vaccine manufacturing
Separately, GSK  reached an agreement in principle with Novavax Inc. (NASDAQ:NVAX) to support manufacturing of up to 60 million doses of COVID-19 vaccine NVX-2373. GSK will provide fill-finish capacity at its Barnard Castle facility in England. A rapid technology transfer will begin immediately between the pharma and Novavax, which are negotiating final deal terms.

Amazon’s diagnostic authorized
FDA granted an EUA for the Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2 from the STS Lab Holdco subsidiary of Amazon.com Inc. Nasal swabs for the assay may be collected under medical supervision or unsupervised at home in individuals with or without COVID-19 symptoms, and are sent to CLIA labs that run the tests.

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