Asia-Pacific Roundup: Medsafe grants provisional approval to Novavax COVID vaccine

RoundupsRoundups | 23 August 2022 |  By 

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has granted provisional approval to Novavax’s COVID-19 vaccine Nuvaxovid for use in adolescents 12 years and older. A day earlier, Medsafe granted provisional approval to Nuvaxovid as a first or second booster in adults regardless of previous COVID-19 vaccine status.
 
Nuvaxovid’s provisional approval as a booster was granted based on data from Phase 2 trials conducted in Australia, South Africa, and the UK where adult participants received a booster dose approximately 6 months after completing their primary vaccination series. The results showed similar or increased immune responses compared to Phase 3 trials that evaluated the primary COVID-19 vaccine series and demonstrated a significant antibody response when used as a heterologous booster dose.
 
Among 2,247 adolescents enrolled in the pediatric expansion to the Phase 3 PREVENT-19 trial, Nuvaxovid had 80% efficacy against preventing COVID-19 when the B.1.617.2 (Delta) variant of SARS-CoV-2 was dominant, and the vaccine was well tolerated, according to a statement from Novavax.
 
“We are pleased to offer a protein-based COVID-19 vaccine choice as a primary series to New Zealanders aged 12 and older and as a booster for adults 18 and older,” Stanley C. Erck, Novavax president and chief executive officer, stated in the release. “Providing Nuvaxovid now for adolescents may help increase vaccination rates amidst rising cases of COVID-19.”
 
New Zealand joins other countries that have authorized or approved Nuvaxovid. The vaccine has been granted provisional approval by the Therapeutic Goods Administration (TGA), received marketing approval from the Japan Ministry of Health, Labour and Welfare, was granted a Biological License Application (BLA) approval from South Korea's Ministry of Food and Drug Safety (MFDS), and has been approved in Canada. It is also authorized for emergency use in over 40 countries.
 
Medsafe
 
Philippine FDA launches Taskforce Edward to increase access to COVID vaccines
 
The Philippine Food and Drug Administration (FDA) recently announced the launch of “Taskforce Edward,” an initiative intended to increase commercial access to COVID-19 vaccines for people living in the Philippines. Named after Dr. Edward Jenner, creator of the first vaccine, Taskforce Edward is part of a shift in the Philippines from “COVID-19 crisis management to a more robust recovery of the national economy,” according to a statement.
 
The initiative will create a team of experts dedicated to streamlining evaluation and approval of COVID-19 vaccines and issue Certificates of Product Registration (CPR) in place of emergency use authorizations. A COVID-19 vaccine granted a CPR can be distributed from an FDA-licensed drug facility and serves as an “assurance that any post-market issues will be addressed through a more rigorous surveillance and pharmacovigilance,” FDA said.
 
“To date, only one COVID-19 vaccine EUA holder has submitted an application for the issuance of CPR,” FDA wrote in the release. “To this end, Director General Dr. Samuel Zacate encourages the pharmaceutical industry to apply and complete the requirements necessary for the issuance of CPR or a marketing authorization in support of this Taskforce Edward instituted by the FDA.”
 
Press release
 
 Australia’s TGA investigates potential contamination of quinapril medicines
 
Some quinapril products worldwide may have been contaminated with low levels of a nitrosamine impurity, N-nitroso-quinapril. Australia’s TGA announced it is investigating supplies of quinapril products as well as quinapril combined with hydrochlorothiazide for low levels of N-nitroso-quinapril.
 
Pfizer Australia has paused their supply of quinapril products during the investigation and has recalled all quinapril products from pharmacies with unacceptable levels of N-nitroso-quinapril, according to TGA. The company also has notified TGA of a shortage of these products based on this recall.
 
“Consumers are advised to continue to take their quinapril medicines as prescribed. Patients should not stop taking their quinapril medicines unless instructed to by their health professional,” TGA said.
 
More broadly, TGA and other international regulators have been investigating nitrosamine impurities in other medicines and working with sponsors to address this issue.
 
TGA Alert
 
Sabizabulin granted provisional determination as COVID treatment in Australia
 
Australia’s TGA has granted provisional determination to the oral first-in-class small molecule sabizabulin to treat COVID-19.
 
Provisional determination is the first step to apply for provisional registration in Australia and is not a guarantee the medicine will be approved in the country, TGA said.
 
Recent data from Phase 2 and Phase 3 trials shows sabizabulin significantly reduced mortality in patients hospitalized with COVID-19, according to a statement from drug maker Veru Inc. The Phase 3 trial was halted early due to efficacy, based on the recommendations of an independent data monitoring committee.
 
“It is currently winter in Australia and the COVID death rate in Australia in hospitalized COVID-19 patients who are at risk for ARDS remains unacceptably high with current standard of care. By reducing deaths in hospitalized COVID-19 patients, sabizabulin has great potential to play a critical role in the battle against COVID-19 infections,” Mitchell Steiner, MD, chairman, president, and chief executive officer at Veru, stated in a press release.
 
Press release
 
TGA releases guidance on active medical devices
 
TGA has issued new guidance on the requirements for active medical devices that use electricity or other energy to operate.
 
An active device is defined by TGA as needing energy not provided by gravity or humans to operate, and includes devices like pacemakers, electric hospital beds, software, x-ray machines, lung ventilators, and ultrasound machines, among other devices.
 
The guidance outlines a definition of an active device, summary of requirements, different energy types, and safety requirements for electromedical devices. It also defines telecommunications and radio-communications transmitters, radioactive and radiating medical devices, and programmed and programmable medical devices.
 
Guidance
 
TGA issues guidance on exemption criteria for clinical decision support software
 
Australia’s TGA has released guidance outlining the requirements for clinical decision support software (CDSS) to qualify for exemption from existing software-based medical device requirements.
 
The guidance is a complement to the TGA’s guidance on CDSS released in February 2021.
 
A CDSS package is considered exempt if it is a medical device that supports clinical decisions and makes a medical recommendation to a health professional involving a disease, defect, ailment, or injury without replacing their clinical judgment or processing or analyzing data from another medical device.
 
Guidance
 
TGA seized more than $2 million in counterfeit therapeutic goods
 
As part of Interpol’s Operation Pangea, TGA helped intercept over $2 million in counterfeit therapeutic goods, the regulatory agency announced.
 
Overall, Interpol’s operation seized approximately US$11 million of products in 94 countries over the course of a week, including counterfeit anabolic steroids, antibiotics, COVID-19 rapid antigen tests, cosmetic injectables, erectile dysfunction medicines, herbal and sports supplements, ivermectin, nicotine vaping products, pain killers and sedatives, TGA said.
 
TGA specifically collaborated with law enforcement in Australia to seize 860,000 units of illegally imported products with an estimated value of AU$2 million, “a significant disruption of dangerous medicines,” they said.
 
TGA Notice
 
TGA announces post-market review of ventilators, CPAP and BiPAP devices
 
TGA is conducting a postmarket review of continuous and non-continuous ventilators, acute care ventilators, ambulatory ventilators such as continuous positive airway pressure (CPAP) devices, and bi-level positive airway pressure (BiPAP) devices.
 
TGA said the purpose of the post-market review is to ensure the devices meet Australian Register of Therapeutic Goods (ARTG) essential principles and that the devices are safe for use.
 
The review follows the recent identification of a safety hazard from the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices that may degrade over time and pose a health risk.
 
TGA is asking sponsors of these devices to provide information on the type of soundproofing present in the devices and whether the devices could present a health hazard to users.
 
TGA Notice
 
Other news
 
The Drugs Controller General of India (DCGI) has approved AstraZeneca India’s Lynparza (Olaparib) as an adjuvant treatment for BRCA-mutated HER2-negative high-risk early breast cancer in adult patients who had previously undergone neoadjuvant or adjuvant chemotherapy. The approval was based the Phase 3 OlympiA trial, which showed significant improvement in a secondary endpoint of overall survival for patients receiving the PARP inhibitor, with a 32% reduction in mortality compared to placebo. Press release
 
Doughbot Enterprises Pty Ltd and an officer of the company were fined AU$87,312 by TGA stemming from 13 infringement notices related to unlawful advertising of nicotine vaping products on websites and social media. TGA also announced proceedings in the Federal Court against two other companies and their executive officers, Prefixx Pty Ltd and Vapor Kings Pty, related to illegal advertisements of nicotine vaping products. TGA Notice
 

 

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