With COVID-19 vaccines availability becoming an issue and countries such as Ghana struggling to get in more vaccines to meet herd immunity targets, the World Health Organisation (WHO) has just listed an additional COVID-19 vaccine for emergency use globally.
According to the global body, the Sinopharm COVID-19 vaccine could help boost supply to underserved countries. Its easy storage requirements make it highly suitable for low-resource settings.
Beijing Bio-Institute of Biological Products Co Ltd, subsidiary of China National Biotec Group (CNBG), produced the Sinopharm vaccine.
A statement by the WHO made available to ghanabusinessnews.com said it is the first vaccine that will carry a vaccine vial monitor, a small sticker on the vaccine vials that change color as the vaccine is exposed to heat, letting health workers know whether the vaccine can be safely used.
“The addition of this vaccine has the potential to rapidly accelerate COVID-19 vaccine access for countries seeking to protect health workers and populations at risk,” Dr Mariângela Simão, WHO Assistant-Director General for Access to Health Products, is quoted as saying.
The WHO is urging the manufacturer of the vaccine to participate in the COVAX Facility and contribute to the goal of more equitable vaccine distribution.
The WHO’s Emergency Use Listing (EUL) is a prerequisite for COVAX Facility vaccine supply and also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
The EUL assesses the quality, safety and efficacy of COVID-19 vaccines, as well as risk management plans and programmatic suitability, such as cold chain requirements. This procedure assesses the suitability of novel health products during public health emergencies.
The objective is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency, while adhering to stringent criteria of safety, efficacy and quality.
In the case of the Sinopharm vaccine, the WHO assessment included on-site inspections of the production facility. The WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) has completed its review of the vaccine.
The statement noted that on “the basis of all available evidence, WHO recommends the vaccine for adults 18 years and older, in a two-dose schedule with a spacing of three to four weeks. Vaccine efficacy for symptomatic and hospitalized disease was estimated to be 79%, all age groups combined.”
Adding that few older adults (over 60 years) were enrolled in clinical trials, so efficacy could not be estimated in this age group.
“Nevertheless, WHO is not recommending an upper age limit for the vaccine because preliminary data and supportive immunogenicity data suggest the vaccine is likely to have a protective effect in older persons,” the statement said.
WHO also listed the Pfizer/BioNTech vaccine for emergency use on 31 December 2020; two AstraZeneca/Oxford COVID-19 vaccines on February 15, 2021, produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India; and COVID-19 vaccine Ad26.COV2.S developed by Janssen (Johnson & Johnson) on March 12, 2021.
Meanwhile, in a joint statement on transparency and data integrity, the International Coalition of Medicines Regulatory Authority (ICMRA) and the WHO is calling on the pharmaceutical industry to provide wide access to clinical data for all new medicines and vaccines, whether full or conditional approval, under emergency use, or rejected.
The statement said clinical trial reports should be published “without redaction of confidential information for reasons of overriding public health interest.”
It noted that the “COVID-19 pandemic has brought into sharp focus the need for information and data to support academics, researchers and industry in developing vaccines and therapeutics; to support regulators and health authorities in their decision-making; to support healthcare professionals in their treatment decisions; and to support public confidence in the vaccines and therapeutics being deployed.”
Adding that the common aim of these initiatives is to ensure that results of research are accessible to all those involved in health care decision-making.”
“The priority should be for new innovative medicines and vaccines. This improves transparency and strengthens the validity and value of the scientific evidence base. To succeed, initiatives need multi-stakeholder engagement aimed at finding solutions that deliver benefits for public health.”
“Regulators continue to spend considerable resources negotiating transparency with sponsors. Both positive and negative clinically relevant data should be made available, while only personal data and individual patient data should be redacted,” it added.
By Eunice Menka
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