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Asia-Pacific Roundup: TGA publishes COVID vaccine safety monitoring plan

Posted 16 February 2021 | By Nick Paul Taylor 

Asia-Pacific Roundup: TGA publishes COVID vaccine safety monitoring plan

Australia’s Therapeutic Goods Administration (TGA) has published a five-point plan detailing the enhanced measures it will put in place to ensure the timely identification and mitigation of safety issues during the roll out of COVID-19 vaccines.
 
The agency aims to “strengthen the existing vaccine vigilance system for early detection and investigation of suspected side effects,” thereby enabling it to manage emerging safety issues and maintain public confidence.
 
Specifically, TGA is putting into place an enhanced adverse event reporting process to ensure the timely collection and management of reports; forms will be particularized for each vaccine and will be sharable between its staff and regional officials.
 
The agency also seeks to enhance safety signal detection and investigation by ensuring it has the capacity to perform timely reviews of adverse event reports and the ability to collaborate in real time with AusVaxSafety, the national vaccine safety system. Upon identification of a safety concern, TGA will “use legislative provisions available to achieve effective and timely regulatory action” that may help to address or reduce the emerging risk.
 
TGA also will ensure information quickly reaches consumers, health professionals and sponsors and will proactively monitor media reports to proactively identify public concerns about vaccine safety.
 
To achieve those goals, TGA plans to collaborate with officials and experts in Australia on the consolidation of “timely information sharing, communication and collaboration with national stakeholders on COVID-19 vaccine safety,’ as well as with officials overseas.
 
The publication of the plan follows the provisional approval of Comirnaty (Pfizer/BioNTech) and the start of a national vaccination strategy that is initially targeting around 700,000 people, including quarantine and border workers and the residents and staff at aged and disability care facilities.
 
Monitoring Plan
 
Indian state asks national government to halt supply of COVID vaccine
 
The Indian state of Chhattisgarh has asked the national government to stop sending shipments of Covaxin, the COVID-19 vaccine made by Bharat Biotech, amid concerns about the lack of late-phase data on the vaccine.
 
India cleared Covaxin, a locally developed vaccine, for restricted emergency use at the start of the year. The action drew immediate criticism from groups including All India Drug Action Network, which said it was “shocked” and “baffled” by the decision to clear the vaccine for use before Bharat completed Phase 3 development.
 
TS Singh Deo, health minister in the Chhattisgarh government, has asked for the stoppage because  of “concern among the community” about the vaccine and “a sense of hesitancy regarding its use” due to the lack of full Phase 3 data on its use. He also noted that Covaxin vials lack an expiry date.
 
The Indian national health minister, Harsh Vardhan, took a different view, taking to Twitter to ask if “is it really befitting of a state’s Health Minister ... to stoke inhibitions regarding” the efficacy of a COVID-19 vaccine. Vardhan added that “in such unprecedented times” Singh Deo should help address any vaccine hesitancy and “do what is in best interest of people, not further vested interests.”
 
Vardhan voiced the same concerns in a formal response to his state-level counterpart. In the letter, Vardhan said the vaccine “is safe and immunogenic,” adding that Singh Deo’s concern about the lack of an expiry date is “completely unfounded” as the information is included on vials’ label.
 
Chhattisgarh Letter, Government Response, Reuters
 
Pakistan permits private imports of COVID vaccines, exempts shots from price controls
 
The Drug Regulatory Authority of Pakistan (DRAP) is permitting private enterprises to bring COVID-19 vaccines into the country and exempting the imports from price controls.
 
Under the policy, COVID-19 vaccines will be exempt from price caps for six months or until “market prices of those vaccines become available.” The exemption applies to vaccines that are registered for emergency use authorization and imported for sale in hospitals and institutions. Vaccines cannot be “sold or distributed in the market” if they are to benefit from the exemption.
 
The changes come as Pakistan, which is home to 220 million people, seeks to protect its population in the absence of major supply agreements. Pakistan’s immunization campaign got underway after China donated 500,000 doses of Sinopharm’s vaccine but will only expand significantly when it starts to receive millions of doses under the COVAX initiative and an agreement with CanSino Biologics.  
 
DRAP Notice, Reuters, More
 
India’s NPPA to stop accepting hard copies of retail price fixation form
 
India’s National Pharmaceutical Pricing Authority (NPPA) is set to stop accepting physical copies of a form related to the retail price fixation of new drugs starting 1 April.
 
The change applies to the Form I companies use to apply for the pricing of new drugs. Historically, companies have sent paper copies of the form to NPPA. However, last year NPPA set out plans to streamline its processes, in part by moving to a fully digital system of Form I submissions.
 
NPPA pointed to the faster processing times that have resulted from the shift to online submissions of new drug applications to justify the change and explain the benefits that may arise from the new way of working.
 
NPPA Notice
 
Other News:
 
DRAP has asked manufacturers of products that contain gluten or lactose to add warnings about the allergens to their labels. The patient information leaflet and primary or secondary packaging should state the product contains gluten or lactose to guide patients who are allergic to the substances. DRAP took the action after hearing about patients suffering from Celiac disease. DRAP Notice
 
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has published a circular on desktop evaluations of good manufacturing practices at overseas pharmaceutical manufacturers. The release of the text comes as NPRA seeks to maintain aspects of its inspection program despite restrictions on travel related to the COVID-19 pandemic. NPRA Notice (Malaysia)
 
An Indian regulatory committee has said convalescent plasma showed no statistically significant difference in clinical outcomes over the control intervention in a Phase 2 clinical trial. SEC Notice

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