Calling it a “a critical milestone in its fight against COVID-19,” Health Canada authorized the Pfizer Inc./Biontech SE COVID-19 vaccine for people age 16 or older.
The Dec. 9 authorization came just two days after the U.K. began administering the vaccine, which it conditionally approved last week. The U.K. was the first Western country to authorize BNT-162b2, making it the first messenger RNA drug to be approved.
The Canadian government announced earlier in the week that Pfizer is set to provide it with up to 249,000 doses of the vaccine during December. Since the vaccine requires two doses 21 days apart, that would be enough to vaccinate fewer than 125,000 people.
Health Canada began an independent rolling review of the vaccine Oct. 9. Based on studies in about 44,000 participants, the vaccine was 95% effective in preventing SARS-CoV-2 infections beginning in the first week after the second dose. “This means that people may not be protected against COVID-19 disease until at least seven days after the second dose,” Health Canada said.
The Public Health Agency of Canada added, “As welcome as this news is amid our ongoing concerns of rapid growth and increasing severe outcomes, it does not mean that control of COVID-19 will be soon or quick.”
As a condition of the Canadian authorization, Pfizer and Biontech must continue to provide Health Canada with information on the vaccine’s safety, efficacy and quality to ensure its benefits are demonstrated in the real world. The agency said the manufacturers plan to follow study participants for two years following their second vaccine dose.
The manufacturers also are testing the vaccine in children of all age groups to see if it’s safe for pediatric use.
Sacklers threatened with House subpoena
After members of the Sackler family, the former owners of Purdue Pharma LP, declined an invitation to testify Dec. 8 before the U.S. House Oversight and Reform Committee, the committee extended a second invitation that the Sacklers may not be able to refuse.
In separate letters to attorneys for the family members, Committee Chair Carolyn Maloney (D-N.Y.) set a new hearing date and gave Richard Sackler, David Sackler, Kathe Sackler and Mortimer Sackler the choice of voluntarily appearing before the committee Dec. 15 or being subpoenaed to appear.
Maloney noted in the Dec. 8 letters that the family had declined the first invitation due to ongoing bankruptcy proceedings. “The existence of separate proceedings outside the Legislative Branch does not affect the Committee’s authority to hold hearings with your clients,” Maloney told the family’s attorneys.
In October, the committee released selected documents that it had obtained as part of its investigation into Purdue’s marketing of Oxycontin (oxycodone hydrochloride) and other opioid products. In Tuesday’s letters, Maloney said those documents showed that the Sacklers were “closely involved” in the Stamford, Conn., company’s efforts to grow the market share for its opioid products, even after entering into a $600 million settlement with the Department of Justice on charges of misleading the public about Oxycontin’s risk.
“Your clients’ testimony is critically important to the Committee’s interest in examining the opioid epidemic in order to inform legislative efforts to address this crisis,” Maloney wrote to the attorneys.
DEA proposes de-scheduling Alkermes drug
Following the recommendation of the U.S. Department of Health and Human Services (HHS), the Drug Enforcement Administration (DEA) is proposing the removal of samidorphan and its salts from all Controlled Substance schedules.
Currently, samidorphan is listed as a schedule II drug because it can be derived from opium alkaloids, according to a DEA notice to be published in the Dec. 10 Federal Register. The HHS recommendation for removal is based on an FDA scientific and medical evaluation that found samidorphan doesn’t meet the criteria for inclusion on any of the controlled substance schedules.
In making that determination, the FDA considered eight factors and findings related to the substance’s abuse potential, legitimate medical use and dependence liability.
Samidorphan has yet to get FDA approval, but it is one of the active ingredients in Alkermes plc’s ALKS-3831, a combination drug developed to treat schizophrenia and bipolar I disorder in adults. Alkermes, of Dublin, received a complete response letter last month requesting manufacturing documents.
Although an FDA advisory panel endorsed the drug, which also includes olanzapine, some committee members were concerned about its risks due to the opioid antagonist qualities of samidorphan.
Comments about the DEA’s proposed rule or requests for a hearing should reference Docket No. DEA-665 and be submitted by Jan. 9.
Marburg MCMs protected under PREP
Exercising his authority under the U.S. Public Readiness and Emergency Preparedness (PREP) Act, HHS Secretary Alex Azar issued a declaration providing liability immunity to certain individuals and entities against any claim of loss related to the manufacture, distribution, administration or use of medical countermeasures (MCMs) against marburgvirus or Marburg disease.
MCMs covered under the declaration include drugs, vaccines, diagnostics and devices used to treat, diagnose, cure, prevent or mitigate Marburg disease or the transmission of marburgviruses. Also included are devices used in administering an MCM and all the components of the product, as well as countermeasures for adverse effects of the MCMs.
In making the declaration, Azar said he has determined that Marburg disease and marburgviruses are a credible risk and may, in the future, constitute a public health emergency. The declaration is intended to encourage the development of MCMs targeting the deadly virus.
OPDP: Don’t make risks a P.S.
The FDA’s Office of Prescription Drug Promotion (OPDP) issued its first untitled letter of the year to Azurity Pharmaceuticals Inc., of Wilmington, Mass.
Posted to the FDA website this week, the letter takes issue with an email intended for health care professionals that OPDP said misbrands Xatmep (methotrexate). The drug is approved to treat pediatric patients with acute lymphoblastic leukemia as part of a multiphase, combination chemotherapy maintenance regimen. Associated with a number of serious risks, Xatmep’s label contains a boxed warning describing severe toxic reactions, including embryo-fetal toxicity.
While the benefits of Xatmep are prominently presented in the body of the email in a bulleted list, the limited risk information, including the boxed warning, appears almost as a postscript (P.S.) following the signature block, which typically signals the end of a correspondence.
“As such, the email fails to … present the limited risk information included in the email with a prominence and readability reasonably comparable to the presentation of information relating to the benefits of the drug,” OPDP said in the letter.
Also, one of the benefit claims in the body of the email suggests Xatmep is approved for all ages without mentioning that it’s part of a combination maintenance therapy. OPDP noted the full indication is included in the email, but like the boxed warning, it appeared below the signature.
While the letter is OPDP’s first untitled letter in 2020, the office has sent five warning letters this year in response to other prescription drug promotions.
U.S. Senators sound off on E&M offsets
The final U.S. Medicare physician fee schedule (MFPS) for calendar year 2021 included a much sought-after boost in rates paid to physicians for evaluation & management (E&M) services, but the requirements for budget neutrality have dinged other rates.
The offsets drew the ire of physician specialty societies and the attention of a number of senators, who penned a Dec. 4 letter to the Senate leadership urging that legislation to temporarily override the budget neutrality requirement.
The 46 senators who signed onto the letter made a bipartisan argument that the offsets would be problematic in ordinary times, and that any such cuts imposed during the pandemic would be even more of a hazard to the continuity of many medical practices, and thus jeopardize access for Medicare beneficiaries.
The cuts are slated to go into force Jan. 1. Congress has one obvious legislative vehicle for such an override – the spending agreement needed to sustain government operations past Dec. 11.