Asia-Pacific Roundup: Vietnam seeks mRNA tech transfer for local COVID vaccine production

The Vietnamese health ministry has met with the World Health Organization (WHO) to discuss the transfer of the technology needed to manufacture mRNA vaccines in the country.
 
Vietnam received a shipment of 811,200 doses of the COVID-19 vaccine developed by AstraZeneca and the University of Oxford via the COVAX Facility at the start of last month. Around 900,000 people have now received a vaccine, but the supply of doses remains a constraint on the pace of the rollout, leading the health ministry to approach WHO to “facilitate the negotiations on transferring of mRNA technology.”
 
The negotiations, details of which were reported on by state-run media outlet Vietnam News Agency (VNA), form part of a wider debate about how to boost global access to COVID-19 vaccines. Moderna Therapeutics, one of the leading mRNA vaccine manufacturers, vowed not to enforce its COVID-19 patents during the pandemic, but relatively few plants are equipped to make such products.
 
WHO set out plans to help more low- and middle-income countries (LMICs) to make mRNA vaccines last month. The idea is to establish hubs that will transfer a comprehensive technology package and train manufacturers in LMICs. Vietnam could benefit from the WHO program if it has manufacturers that meet the criteria.
 
VNA framed Vietnam’s interest in accessing mRNA technology as, in part, a result of the fact, “The COVID-19 situation is showing complicated developments.” The seven-day rolling average of daily new COVID-19 cases in Vietnam has increased by more than 800% over the past month and is now well above the highs hit during earlier waves.
 
VNA
 

China commits to resolving problems faced by foreign pharma companies

The Ministry of Commerce of China (MOFCOM) has vowed to do more to support foreign-invested pharmaceutical companies after meeting with businesses including Roche and Takeda Pharmaceutical.
 
Wang Wentao, who took over as the minister of commerce late last year, said MOFCOM will work with relevant government departments and local authorities to address difficulties and issues reported by foreign pharma companies in a timely manner.
 
The minister also wants MOFCOM, in collaboration with other Chinese departments and authorities, to communicate better with foreign companies and provide them with better supporting services. Details of what the commitments will mean in practice are yet to emerge.
 
MOFCOM framed the proposals as part of plans by the top leaders of the Chinese Communist Party to stabilize “the fundamentals of foreign trade and investment,” noting that in recent years China has worked to expand market access and improve the legal system for overseas companies. The stated goal of the activity is to integrate China into the world economy and create a better environment for businesses.
 
Officials from Chinese agencies including the National Medical Products Administration (NMPA) attended the MOFCOM event. MOFCOM said the officials took questions to address the concerns of the 15 foreign pharma companies at the event. The ministry did not share details of the concerns, but China has been criticized in the past for policies that provide “unfair support” to local companies and threaten to “slow global life sciences innovation.”
 
Press Release
 

TGA prepares fecal microbiota transplant industry for upcoming rule changes

Australia’s Therapeutic Goods Administration (TGA) has published a summary of how the regulation of fecal microbiota transplant (FMT) products is changing to help providers and manufacturers get ready for the new rules.
 
TGA shared details of the new regulatory model for FMT products in Australia at the start of last year. With the 18-month transition period to the new rules set to end on 1 July, the agency has provided an overview of what is set to change and the actions FMT manufacturers and providers need to take to ensure compliance with the incoming requirements.
 
Starting in July, FMT products will need to be in the Australian Register of Therapeutic Goods and manufacturers and providers will have to comply with requirements on advertising, adverse event reporting and certain TGA standards.
 
The FMT industry has had longer than originally proposed to prepare for the changes. TGA originally planned to give the industry 12 months to prepare, but granted it a six-month extension in light of delays caused by the COVID-19 pandemic.
 
TGA Notice
 

Indian states start prophylactic use of ivermectin in defiance of WHO advice

Several Indian states have begun distributing the antiparasitic drug ivermectin to residents in a bid to curb the spread of COVID-19. The states took the actions despite WHO, leading global regulators and ivermectin manufacturer Merck recommending against the use of the drug to stop COVID-19.
 
Vishwajit Rane, the minister for health in the Indian state of Goa, said the prophylactic use of the drug will “help us in reducing the mortality rate” and “speed up the recovery process of patients.” In Uttarakhand, the state government is distributing six ivermectin tablets to people aged 15 years and older. The government wants people to take two tablets a day for three days.
 
The rollout of ivermectin against COVID-19, which is also underway in the state of Karnataka, goes against the recommendation of multiple organizations. WHO said evidence on whether ivermectin reduces mortality and other negative COVID-19 outcomes is “very low certainty.” The European Medicines Agency (EMA) said there is a lack of evidence supporting the use of ivermectin to prevent or treat COVID-19, adding that the high doses used in coronavirus studies carry safety concerns.  
 
Faced with high numbers of COVID-19 cases, some Indian states have decided the potential benefits outweigh the risks. Goa, Karnataka and Uttarakhand all suffered fast-rising case counts in April and into May, although numbers are now falling.
 
Rane Post, Livemint
 

CDSCO shares advice on using oxygen concentrators to manage COVID-19 at home

India’s Central Drugs Standard Control Organization (CDSCO) has shared advice on the home use of oxygen concentrators in the management of COVID-19.
 
CDSCO issued the notice in light of concerns that people are using concentrators that are not suited to the management of COVID-19. The regulator said the devices can be used at home and in care centers, provided they have a flow capacity of at least five liters per minute and deliver oxygen at a concentration of 90% or more.
 
With some devices delivering as little as one liter a minute of oxygen, at varying concentrations, there is a risk that people will inadvertently use products that are incapable of managing COVID-19. Recognizing that, CDSCO is trying to raise awareness of the minimum requirements.
 
The regulator is strongly advising sellers to prominently display the continuous flow capacity, oxygen concentration and maximum retail price of their devices. CDSCO also advised against the use of the label “for home-based COVID care” on products that do not meet the minimum requirements on the grounds that it is misleading.
 
CDSCO Notice
 

Other News:

The China-EU Pharmaceutical Working Group has met virtually to discuss topics including impurity testing and remote inspections. Emer Cooke, the executive director of EMA, was among the people to attend the event. NPRA Notice (Chinese)
 
The Korean Ministry of Food and Drug Safety (MFDS) has reported the continued growth in clinical trials amid the disruption caused by the COVID-19 pandemic. MFDS Notice (Korean)