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Rollout of Johnson & Johnson’s COVID-19 Vaccine Resumes in Europe
Pfizer and BioNTech have also made a new COVID-19 vaccine supply agreement with the EU, while self-administered COVID tests start shipping in US.
Johnson & Johnson recently announced that the rollout of its COVID-19 vaccine will resume in Europe.
The European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC) provided updated guidance for use of the vaccine and confirmed the overall benefit-risk profile remains positive.
The guidance follows a PRAC review of a small number of cases of a rare adverse event involving blood clots in combination with low platelet counts, a Johnson & Johnson spokesperson said. Generally, the adverse event occurred one to three weeks following injection of the vaccine.
“The safety and well-being 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,” Paul Stoffels, MD, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson said in the announcement.
“We strongly believe in the positive benefits of our single-shot, easily transportable COVID-19 vaccine to help protect the health of people everywhere and reach communities in need globally,” Stoffels continued.
Following the PRAC recommendation, Johnson & Johnson will resume shipment of its COVID-19 vaccine in the EU, Norway, and Iceland. The updated EMA and Healthcare Professionals guidance will be available to national healthcare authorities as well.
The company will also update its COVID-19 vaccine Summary of Product Characteristics and Package Leaflet to include information on the diagnosis and management of the adverse event.
Pfizer, BioNTech to Supply 100M Doses of Vaccine to EU Member States
Pfizer and BioNTech recently announced that they will supply an additional 100 million doses of their COVID-19 vaccine, Comirnaty, to EU member states in 2021.
The additional purchase brings the total number of vaccine doses to be delivered to the 27 member states to 600 million.
Sean Marett, chief business and chief commercial officer at BioNTech stated that the additional 100 million doses will help support the acceleration of the vaccination campaigns through the EU.
The 600 million will cover two-thirds of the EU population and is currently the largest cumulative supply agreement for Comirnaty globally.
Moderna Announces Supply Agreement With Israel for its Vaccine
Moderna recently announced a new supply agreement with Israel for 2022.
Under the terms of agreement, Israel has the option to purchase doses of one of Moderna’s variant-specific COVID-19 vaccine candidates, subject to regulatory approval.
The recent announcement follows two earlier agreements between Israel and Moderna to supply a total of 10 million doses of COVID-19 Vaccine Moderna.
Back in January, Israel’s Ministry of Health (MOH) secured 6 million doses of Moderna’s vaccine candidate based on data from the company’s Phase 3 trial.
In the trial, researchers found that COVID-19 Vaccine Moderna was 94.1 percent effective against the coronavirus. Due to positive results, MOH authorized the vaccine for use.
Currently, Moderna’s variant-specific booster vaccine is being studied in human clinical trials. So far, preclinical results have shown that the candidates were effective against the virus.
Abbott Begins Shipping COVID-19 AG Self-Test to Retailers
Abbott recently announced that it began shipping its BinaxNOW COVID-19 Ag Self Test to retailers across the country. Broader nationwide availability is expected within the next few weeks.
The BinaxNOW Self Test will be available over the counter at CVS Pharmacy, Walgreens, and Walmart without a prescription. This initiative is part of Abbott’s commitment to get the US’ most studied COVID-19 rapid tests to as many Americans as possible, the company said.
The test will be sold in a pack of two for about $23.99, making it the most affordable over-the-counter COVID-19 rapid test available in the country.
At the end of December, FDA issued an emergency use authorization for the BinaxNOW Ag Self Test. The test is authorized for individuals 15 years of age or older who are suspected of having COVID-19 by their healthcare provider and who are within seven days of symptom onset.
