UK opens up COVID-19 vaccination to pregnant women The UK’s Joint Committee on Vaccination and Immunisation (JCVI) says that pregnant women should be offered either the Pfizer/BioNTech or Moderna COVID-19 vaccines.
It is the first country to open up vaccination to pregnant women: given that Phase 3 trials did not cover this group resulting in a lack of data.
However, studies covering around 90,000 women in the US have since been carried out, which have not raised any safety concerns (results published last month in the American Journal of Obstetrics and Gynecology last month also showed the two mRNA vaccines were
The EU has entered into negotiations with Pfizer/BioNTech for a third COVID-19 vaccine contract: which would see delivery of 1.8 billion doses of the vaccine between 2021-2023.
The contract would specify that production of the doses, including production of essential components, would be based in the EU.
As of last month, the two companies had signed orders for a combined total of 1.4 billion doses for this year (although this total is expected to rise). The EU’s new mega order, therefore, is the first of its scale as well as being the first to set up longer term supplies. As with previous orders, the value of the deal is not being disclosed.
Sterling Pharma Solutions, a global contract development and manufacturing organization (CDMO), has acquired ADC Biotechnology (ADC Bio), a UK based company specializing in antibody-drug conjugates (ADCs).
The move was expected; it follows Sterling’s strategic investment in the ADC Bio business back in December 2020, with the CDMO indicating then the possibility it would take on full ownership of the UK firm in early 2021, subject to due diligence.
ADC Bio have been at the forefront of antibody-drug bioconjugation and process development in recent years. Its Deeside, Wales, UK facility will rebrand to become part of the Sterling Pharma Solutions international network.
Emergent ‘on track’ with COVID-19 vaccine production obligations, J&J takes control of Baltimore plant Emergent BioSolutions Inc yesterday reported that is on target in terms of all its commitments for COVID-19 vaccine production; it also reaffirmed its financial guidance, after a production issue at its Baltimore plant last week saw a massive batch of Johnson & Johnson’s COVID-19 vaccine doses spoiled.
The contract development and manufacturing organization (CDMO) has been producing both the J&J and AstraZeneca vaccines, but mixed up ingredients from the two, causing the loss of 15 million doses, according to the New York Times.
July 2020 saw Emergent sign off on a
UK watchdog: No decision made yet on regulatory action over AstraZeneca shot Media reports claim the UK regulator is set to ban the use of COVID-19 Vaccine AstraZeneca in individuals below the age of 30 over blood clot risk concerns.
Yesterday [April 5], two senior sources from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) told Channel 4 that, while the data is still unclear, there are growing arguments to not administer COVID-19 Vaccine AstraZeneca, now called Vaxzevria, to those younger than 30.
In an emailed statement to BioPharma-Reporter today, the UK watchdog said no conclusions have been drawn as yet in that respect, and the agency continues to review reported adverse effects.