The EMA’s human medicines committee (CHMP) recommended an update to the labeling for Comirnaty to clarify that each vial of Pfizer Inc./Biontech SE’s COVID-19 vaccine may contain six doses – if they’re extracted properly.
Currently, the vials are labeled as having five doses, but health care professionals administering the vaccine have found that the vials generally contain another dose.
To extract six doses from a single vial, CHMP recommends using low dead-volume syringes and needles with a dead volume of no more than 35 microliters. “If standard syringes and needles are used, there may not be enough of the vaccine to extract a sixth dose from a vial,” the EMA said.
If the vaccine remaining in the vial after the fifth dose isn’t enough for a full dose, it must be discarded, the EMA said, and any unused vaccine should be discarded six hours after dilution.
In the U.S., lawmakers are dealing with a different waste issue involving COVID-19 vaccines – the problem of the vaccines expiring before they’re used because administrators are trying to adhere to the government’s tier system that prioritizes who should get the limited doses first.
As a result, providers across the U.S. “have been forced to make decisions on whether to let doses of COVID-19 vaccines expire or to administer them to any willing individuals, even if they are not currently eligible to receive them,” a bipartisan group of 32 members of Congress said in a letter to the CDC last week.
The letter urged the CDC to update its guidance to ensure no vaccine doses go to waste. If such a guidance isn’t forthcoming, the lawmakers said they would seek a legislative solution.
“Strategic allocation must not stand in the way of administering shots to as many individuals as possible given the magnitude of the crisis and the dire projections for cases and deaths in the coming months. Each dose that ends up in the trash is potentially another life lost,” the lawmakers said.
Drug safety in pregnancy mission of new U.K. consortium
The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) announced a new consortium Jan. 11 focused on helping pregnant and breastfeeding women make more informed decisions about the drugs they take.
The Safer Medicines in Pregnancy and Breastfeeding Consortium – comprising the NHS, regulators, and leading third sector and charitable organizations – intends to develop a long-term program to improve the drug information given to women who are thinking about becoming pregnant, are pregnant or are breastfeeding.
In conjunction with the announcement of the consortium, the MHRA established a webpage providing guidance on the use of medicines in pregnancy and breastfeeding. The agency also released an expert working group’s report on optimizing data on drugs used during pregnancy.
The report advises on better capturing and linking existing data on adverse outcomes of pregnancy, capturing relevant information on exposure to all medicines during pregnancy, improving access to relevant data on drugs taken during pregnancy to enable studies to support pharmacovigilance and improving the analytic design of studies examining drug safety in pregnancy.
On a related note, the MHRA issued new guidance Jan. 11 on the use of valproate (Epilim/Sanofi SA) in women and girls of child-bearing age. The guidance is more explicit than a 2018 warning that the antiepileptic drug “must no longer be used in any woman or girl able to have children unless she has a pregnancy prevention program in place.”
The current guidance expressly includes “a ban on the use of valproate for migraine or bipolar disorder during pregnancy, and a ban on the use of valproate to treat epilepsy during pregnancy unless there is no other effective treatment available,” the MHRA said.
Health care professionals prescribing valproate to female patients must make sure they’re enrolled in a pregnancy prevention program and that they complete and sign a risk acknowledgement form when their treatment is reviewed by a specialist, at least annually.
FDA identifies regulatory science needs
In a continuing effort to advance new regulatory tools that are necessary to keep pace with the development and evaluation of innovative products, the FDA has identified several areas in need of continued targeted investment in regulatory science research.
Outlined in a report released Jan. 11, the focus areas of regulatory science (FARS) align with four agency initiatives: public health and preparedness response, increasing choice and competition through innovation, unleashing the power of data, and empowering patients and consumers.
For instance, four FARS have been identified for the data initiative – product safety surveillance, artificial intelligence, digital health and the use of real-world evidence to support the development and approval of new medical products. The FARS-related research will be conducted through intramural and extramural research programs identified by FDA centers and offices, the agency said.
“To stay ahead of evolving regulatory needs, the FARS are designed to be agile to permit regular updating to ensure the FARS include the most current topics for FDA’s research to address to fulfill our regulatory responsibilities,” FDA Chief Scientist Denise Hinton said.
HHS finalizes regulatory review rule
The U.S. Department of Health and Human Services (HHS) finalized a rule requiring its agencies to periodically examine any rules implemented 10 or more years in the past to evaluate whether those rules should be modified or withdrawn.
The 10-year review rule is intended to ensure that the department’s regulations “are having appropriate impacts and have not become outdated,” HHS said, emphasizing the impact on small businesses.
Much of the concern revolving around current approaches to regulatory review hinge on the fact that economic cost-benefit analyses are conducted only upon the publication of a draft rule, but such analyses conducted post-implementation could shed a less favorable light on those benefits and costs. A few months ago, HHS noted that an analysis of existing rules conducted by artificial intelligence found that 85% of all HHS rules finalized before 1990 have not been edited.
While the incoming Biden administration could rescind the new rule, such a review has been a bipartisan goal for years. Each U.S. president going back to Jimmy Carter has issued rules pertaining to periodic review of regulations. President Barack Obama, whom Joe Biden served under, issued an executive order calling for a review of existing significant regulations for potential modification “or repeal … in accordance with what has been learned” regarding the function of those rules.
Doctor pleads guilty to trial fraud
A Miami doctor, Yvelice Villaman Bencosme, pleaded guilty Jan. 8 to falsifying clinical trial data for an asthma drug. Bencosme was the primary investigator for clinical trials conducted at Unlimited Medical Research in Miami. She admitted that, from 2013 to 2016, “she participated in a scheme to defraud an unnamed pharmaceutical company by fabricating the data and participation of subjects” in a pediatric clinical trial, according to the U.S. Department of Justice. She faces a maximum sentence of 20 years in prison.