Covid-19 roundup: Pfizer submits vaccine for full approval; Merkel opposes Biden proposal to suspend IP for vaccines
Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.
How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.
“In this case, since they’re already under emergency use authorization and the large bulk of additional information coming in will be safety data and information on manufacturing, we’re intending to speed that review,” he said.
Pfizer and BioNTech are also awaiting imminent approval for an application to expand the current EUA for their vaccine to include individuals 12 to 15 years of age. The companies said Friday that they intend to submit a supplemental BLA to support licensure of the vaccine in this age group once the required data six months after the second vaccine dose are available.
Merkel opposes Biden proposal to suspend IP for vaccines
Germany’s leader Angela Merkel on Thursday announced her opposition to the Biden administration’s surprise decision to back a World Trade Organization waiver that would suspend intellectual property around the Covid-19 vaccines.
Merkel, according to the Financial Times, said the proposal has “serious implications,” noting that what’s limiting vaccine supplies is not IP, as Moderna CEO Stéphane Bancel also said Thursday, but production capabilities with high-quality standards.
“The protection of intellectual property is a source of innovation and it must remain so in the future,” she said. Germany or any other country that’s a member of the WTO has the power to veto the waiver.
Russia, France and Spain offered support for the US proposal, while other diplomats from Brazil and China said they would discuss it under the WTO framework.
UK calls for those under 40 to not receive the AstraZeneca vaccine
The UK’s Joint Committee on Vaccination and Immunisation on Friday called to restrict the use of the AstraZeneca Covid-19 vaccine to only those who are over 40 years old because of concerns related to rare but potentially fatal cases of blood clots with low platelets.
As of April 28, the UK’s drug regulator received 242 reports of blood clotting cases in people who also had low levels of platelets in the UK, following the use of the AstraZeneca vaccine.
“These numbers are very small compared to the millions of people who have received the vaccine. The overall incidence of case reports of thromboembolic events with low platelets after first or unknown doses was 10.5 per million doses,” the JCVI said.
The committee also noted that the majority of these rare events occurred after the first dose, so, “Everybody who has already had a first dose of the Oxford/AstraZeneca vaccine should receive a second dose of the same jab, irrespective of age, except for the very small number of people who experienced blood clots with low platelet counts from their first vaccination.”
EMA starts rolling review of GSK, Vir monoclonal antibody
The European Medicines Agency on Friday kicked off a rolling review of GlaxoSmithKline and Vir’s Covid-19 monoclonal antibody sotrovimab.
The companies said the decision to start the rolling review is based on the interim analysis of efficacy and safety data from a Phase III trial, which evaluated sotrovimab as monotherapy for the early treatment of COVID-19 in 583 adults at high-risk of hospitalization.
Results of the interim analysis demonstrated an 85% (p=0.002) reduction in hospitalizations over 24 hours or deaths in those receiving sotrovimab compared to placebo, which was the primary endpoint of the trial.
An emergency use application for sotrovimab has also been submitted to the US FDA and Health Canada.
European Commission lays out strategy for developing more therapeutics
The European Commission on Thursday said it would establish a “therapeutics innovation booster” by July to usher the most promising Covid-19 therapeutics from preclinical research to market authorization.
By June, the commission will create a portfolio of 10 potential Covid-19 drugs and winnow that portfolio down to the best five.
“It will organise matchmaking events for industrial actors involved in therapeutics to ensure enough production capacity and swift manufacturing. New authorisations, rolling reviews and joint procurement contracts will be up and running before the end of the year,” the commission said.
By October, the commission said it hopes to have at least three new therapeutics to market, and possibly two more by the end of 2021, with the development of flexible regulatory approaches to speeding up the assessment of drugs that are promising and safe.
CMS increases payments for monoclonal antibodies to incentivize home infusions
The US Centers for Medicare & Medicaid Services are upping their payments for the administration of Covid-19 monoclonal antibodies from $310 to $450 for most health care settings, or $750 when monoclonal antibodies are administered in a beneficiary’s home, including temporary lodgings like hotels, cruise ships or homeless shelters.
“These higher national average payment rates reflect additional information provided to CMS about the costs of providing these services in a safe and timely manner, such as clinical staff and personal protective equipment,” the centers said.
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