Keeping tabs on Covid-19: AstraZeneca hoping to win US approval for their Covid-19 vaccine and J&J resumes its vaccine roll out in Europe

As the pharma industry tackle Covid-19 vaccine manufacturing bottlenecks, AstraZeneca and Johnson & Johnson have announced how they are planning to maximize their vaccine programs in this week’s Keeping tabs update

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AstraZeneca aims to deliver 30 million doses of their vaccine to the US following FDA approval

Concerns around the safety and efficiency of AstraZeneca’s Covid-19 vaccine has continued to be questioned by global health authorities – regulatory bodies in Germany and Canada named as some among the listdespite the European Medicines Agency’s (EMA) backing.

However, regardless of the vilification and doubts around the manufacturer of AstraZeneca’s Covid-19 vaccine, AstraZeneca is still planning to apply for emergency use authorization of its vaccine in the US, Fierce Pharma reported.

Following the Phase 3 US clinical trial of AstraZeneca’s vaccine in March 2021, the vaccine demonstrated efficacy of 79 per cent at preventing symptomatic Covid-19 and 100 per cent efficacy at preventing severe disease and hospitalization. Notably, the vaccine maintained its efficacy in participants aged 65 years and over at 80 per cent.

Days following the initial announcement of the vaccine’s 79 per cent efficiency, the company reduced the figure to 76 per cent. While there was not much of a difference in the figures, the incident placed yet another spotlight on the company's handling of its vaccine program.

AstraZeneca and the independent data safety monitoring board have verified that the clinical trial results indicate that the vaccine was well tolerated by participants in the US and they identified no safety concerns related to the vaccine.

Ann Falsey, Professor of Medicine at the University of Rochester School of Medicine, US, and co-lead Principal Investigator for the trial, said: “Our findings reconfirm previous results observed in [the vaccine’s] trials across all adult populations but it’s exciting to see similar efficacy results in people over 65 for the first time. This analysis validates the AstraZeneca Covid-19 vaccine as a much-needed additional vaccination option, offering confidence that adults of all ages can benefit from protection against the virus.”

Ruud Dobber, vice president of AstraZeneca's biopharmaceuticals business unit, told CNBC: “Assuming that the approval will take place in a fast way, we hope to deliver 30 million doses [of our vaccine to the US] instantly.”

EMA confirms overall benefit-risk profile remains positive for J&J’s Covid-19 vaccine roll out in Europe

Uses of the Johnson & Johnson (J&J) single-shot vaccine was temporarily halted by US regulators after symptoms of rare brain blood clots combined with a low blood platelet count were reported in six women, prompting the company to delay its rollout in Europe.

On April 20, 2021, J&J announced that the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has provided updated guidance for use of the company’s Covid-19 vaccine and confirmed the benefits outweighed the risks.

As a result, J&J will update its Covid-19 vaccine summary of product characteristics and package leaflet to include important information on the diagnosis and management of this very rare adverse event. Healthcare professionals will be alerted to the signs and symptoms of thromboembolism with thrombocytopenia, as well as the appropriate course of treatment.

Following the PRAC recommendation, the company will resume shipment of their Covid-19 vaccine in the European Union, Norway and Iceland.

Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer at J&J, said: “The safety and wellbeing of the people who use our products is our number one priority. We appreciate the rigorous review of the PRAC and share the goal of raising awareness of the signs and symptoms of this very rare event to ensure the correct diagnosis and appropriate treatment.

“We strongly believe in the positive benefits of our single-shot Covid-19 vaccine to help protect the health of people everywhere and reach communities in need globally.”

For more Covid-related solutions, join Pharma IQ and The Sartorius Group for an interactive webinar discussion as we explore how to carry out therapeutic testing for Covid-19 using human lung cells.

To ramp up pharma’s digital transformation strategies in manufacturing, download Rockwell Automation’s critical consideration guide for deploying smart, fast and flexible life science facilities.