Regulation & Policy

A coronavirus vaccine developed by Oxford University and AstraZeneca Plc was approved by the European Commission on 29 January, only hours after the European Medicines Agency gave the product a positive opinion. The approval is the third for a Covid-19 vaccine in the EU. The other two are vaccines developed by Moderna Inc, approved on 6 January, and a vaccine developed by BioNTech SE and Pfizer Inc, approved on 21 December 2020. Authorisation of the AstraZeneca vaccine was based on data showing an efficacy rate of around 60%.

The European Commission is pressing AstraZeneca Plc for more information about why it is unable to deliver the quantities of a coronavirus vaccine, specified in a contract, to the EU member states. In a statement issued on 25 January, the commissioner for health and food safety, Stella Kyriakides, said the company’s answers to its questions about vaccine supply had thus far “not been satisfactory.”

ViiV Healthcare has received US approval for a combination drug to treat HIV-1. Cabenuva (cabotegravir and rilpivirine) is the first injectable, long-acting regimen for the treatment of the viral infection in adults who are on a stable antiretroviral regimen. It was authorised by the Food and Drug Administration after a priority review.

Verquvo (vericiguat), a drug for heart failure, has been approved by the US Food and Drug Administration. It has a novel mechanism of action which demonstrated superiority to  placebo in a Phase 3 trial of 5,050 patients with symptomatic chronic heart failure and left ventricular ejection fraction of less than 45%, following a worsening heart failure event. In the trial, the drug reduced the risk of cardiovascular death or hospitalisation for heart failure, according to the developer Merck & Co Inc.

The European Commission has granted a conditional marketing authorisation for a Covid-19 vaccine developed by Moderna Inc based on clinical data showing an efficacy rate of 94.1%. The vaccine, COVID-19 Vaccine Moderna, is to be administered to people from 18 years of age. It is the second Covid-19 vaccine to be approved by the EU following a recommendation by the European Medicines Agency. The first was a vaccine developed by BioNTech SE and Pfizer Inc. Both vaccines are based on messenger RNA (mRNA) technology.

The US Food and Drug Administration has cautioned against altering the dosing regimen for Covid-19 vaccines launched on the US market, saying that any changes not supported by clinical trial data would be “concerning.” The agency specifically warned against using a single dose regimen and/or administering less than the dose studied in clinical trials.

The UK has approved a second vaccine to prevent Covid-19 paving the way for a stepped up campaign to immunise the population just as hospitals across the country face a sharp rise in admissions from the pandemic. The vaccine, AZD1222, was developed by Oxford University and AstraZeneca Plc and received an emergency authorisation on 30 December – a little more than four weeks after a vaccine from Pfizer Inc and BioNTech was given clearance.

The Covid-19 vaccine developed by BioNTech SE in partnership with Pfizer Inc received a conditional marketing authorisation in the EU on 21 December – only hours after having been given a positive opinion by the European Medicines Agency.

The US Food and Drug Administration has issued an emergency use authorisation to Moderna Inc for a vaccine for Covid-19 following trial data showing it was 94.1% effective in preventing the disease. The decision comes just a week after the agency issued an emergency authorisation for a vaccine developed by BioNTech SE and its partner Pfizer Inc. Both vaccines are based on messenger RNA (mRNA), a technology never before used in a human vaccine. The two vaccines work by instructing cells in the body to make copies of the SARS-CoV-2 spike protein.

Gilead Sciences Inc and Galapagos NV have dropped plans to make a new submission in the US for their small molecule drug Jyseleca (filgotinib) in rheumatoid arthritis (RA) following a meeting with the Food and Drug Administration. The parties discussed the points raised in the agency’s complete response letter in August in which it refused to approve the drug because of concerns about its benefit/risk profile at a dose of 200 mg.