Regulation & Policy

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 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.

The US has become the second western country to give an emergency use authorisation to a Covid-19 vaccine developed by BioNTech SE in partnership with Pfizer Inc. The vaccine, BNT162b2, is based on messenger RNA (mRNA), a technology never before used in a human vaccine. It was given an emergency authorisation by the Food and Drug Administration on 11 December for individuals 16 years and over.

An agreement setting the terms of trade between the UK and the European Union following Brexit remains unresolved, according to the European Commission. The two sides have been negotiating for weeks to reach a trade agreement that would take effect from 1 January 2021. A telephone call on 5 December between the UK Prime Minister Boris Johnson and the European Commission President Ursula von der Leyen did not resolve differences on three issues. These issues are maintaining a level playing field for trade; fishing rights and governance.

The first drug for imaging prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer was approved by the US Food and Drug Administration on 1 December. It is designed to be used with positron emission tomography (PET). The drug, Gallium 68 PSMA-11, is indicated for patients with suspected prostate cancer metastasis who are potentially curable by surgery or radiation therapy. It is also indicated for patients with suspected prostate cancer recurrence based on elevated prostate-specific antigen (PSA) levels.

The UK government has authorised the emergency use of a new vaccine for the prevention of Covid-19 from Pfizer Inc and BioNTech SE – the first approval of a pharmaceutical product based on messenger RNA (mRNA) technology. The decision, announced on 2 December, was based on a recommendation of the Medicines and Healthcare products Regulatory Agency (MHRA), the independent regulator. It follows the publication of Phase 3 data for the vaccine showing that it achieved an efficacy rate of 95%.

Moderna Inc is poised to make regulatory filings in the US and Europe today for its Covid-19 vaccines. This follows the release of new data from a Phase 3 study showing that the messenger RNA (mRNA) vaccine achieved an efficacy rate of 94.1%. The placebo-controlled study involves 30,000 participants.