In light of more EU reports of blood clots in people who received the Astrazeneca plc COVID-19 vaccine, Health Canada said it’s issuing additional terms and conditions to the authorizations of the Astrazeneca and Verity Pharmaceuticals/Serum Institute of India vaccines. The new conditions will require the manufacturers to conduct a detailed risk-benefit assessment of their vaccine by age and sex in the Canadian context. Health Canada will use the information to determine if specific groups of people may be at higher risk of blood clots following vaccination. Health Canada said it will continue to work with its international counterparts to collect and assess the data.
MRNA vaccine efficacy holds in real world
Real-world evidence supports the efficacy of the two-dose mRNA vaccines from Moderna Therapeutics Inc. and Pfizer Inc.-Biontech AG, according to a new study conducted by the U.S. CDC. The study, which looked at the vaccines’ effectiveness in preventing COVID-19 infections among 3,950 health care personnel, first responders and other essential workers in six states over a 13-week period, found that it takes about two weeks after each dose of the vaccines for the body to develop immunities. Two weeks out from a single dose of either vaccine, the study found the risk of infection dropped 80%, and it dropped 90% two weeks after the second dose.
TGA addressing drug shortages
Australia’s Therapeutic Goods Administration (TGA) is seeking comment on reforms intended to help ensure a reliable supply of important medicines. Proposed management strategies include prioritizing the evaluation and registration of certain generics to reduce the risk of shortages and encouraging the registration of more generics of drugs known to be affected by shortages. Another strategy is support for a more reliable supply of drugs registered in other countries that can be imported as substitutes when the Australian drug is in a lengthy or repeated shortage. The consultation closes May 17.
STIs on the rise in U.S.
The U.S. National Academies of Sciences, Engineering and Medicine is calling for modernization of the national surveillance and monitoring systems for sexually transmitted infections (STIs), bolstering the STI workforce, and accelerating the development of vaccines, diagnostics and therapeutics – along with scaling up structural and behavioral interventions. Despite the economic burden and increase of STI rates over the past two decades, funding for the CDC’s STI program has remained flat, according to a new report from the academies. In addition to the limited funding, efforts to control STIs have been hampered by COVID-19, as individuals are delaying routine screenings and STI clinic staff and resources have been diverted to the pandemic response. The report noted increasing rates of chlamydia, gonorrhea and syphilis, adding that one in five people in the U.S. will have an STI in a given year.
CDER firm on Makena withdrawal
The recent publication of the EPPPIC meta-analysis of 31 randomized, controlled trials evaluating the effect of various progestogens in reducing the risk of pre-term birth hasn’t changed the U.S. FDA’s proposal to withdraw its approval of Amag Pharmaceuticals Inc.’s Makena (hydroxyprogesterone caproate injection). Only five of the studies analyzed evaluated singleton pregnancies, the indicated population for Makena, and compared the drug with placebo, the FDA’s Center for Drug Evaluation and Research (CDER) said. In making its recommendation to withdraw approval after Makena didn’t show clinical benefit in a required postmarketing study, CDER said it thoroughly reviewed the five trials in the meta-analysis, which included the failed postmarketing study and the trial used to gain accelerated approval for the drug. Because of how the meta-analysis grouped the trials, CDER said the analysis didn’t “provide relevant information regarding Makena’s effectiveness for its approved use.” The FDA has not yet determined whether it will grant Amag’s request for a public hearing on the proposed withdrawal.