WHO today labeled the Simply arm COVID-19 vaccine for emergency use, providing green light for vaccination worldwide. The Simply arm vaccine was developed by the Beijing book institute of Biological Products Co Ltd, owned by China National Biotechnology Group (CNBC).
“The expansion of this vaccine has the potential to accelerate the availability of COVID-19 vaccines in countries that seek to protect health workers and vulnerable people,” said Dr Marian gels Sinai, Assistant director age metal of Access for Health Products. “We urge manufacturers to participate in the COAX facility and participate in the goal of equitable drug distribution
The WHO Emergency Management Plan (EULOGY) is a requirement for the provision of the COAX vaccine. It also allows countries to speed up their approval for the import and export of COVID-19 drugs.
The EULOGY evaluates the quality, safety and efficacy of the COVID-19 vaccine, as well as risk management systems and its effectiveness, such as cold chain requirements. These tests are performed by a product testing team, comprised of international legal experts and the Technical Advisory Group (TAG), which is responsible for conducting independent tests on whether the vaccine can be registered for emergency use and, if so, under what circumstances.
In the case of the Simply arm vaccine, the WHO test includes a site test.
The product of Simply arm is an inactive vaccine called SARS-CoV-2 Vaccine (Veto Cell). Its simple storage requirements make it ideal for low send settings. It is the first drug and will carry the vaccine, a small sticker on the medicine containers that change color as the drug is exposed to heat, to inform health workers if the vaccine cannot be used safely.
The WHO Vaccination Experts Group (SAGE) has completed a review of the vaccine. According to all available evidence, WHO recommends vaccination of adults 18 years and older, with two doses ranging from three to four weeks. The incidence rate in hospitals is estimated at 79%, including all age groups.
Few older adults (over 60) enrolled in the clinical trials, so efficacy was not limited to this age group. However, the WHO does not recommend the age limit for vaccination because preliminary data and viral support data suggest that the vaccine may have a protective effect on the elderly. There is no reason to believe that the vaccine has a different safety profile for adults and teens. The WHO therefore recommends that countries that use vaccines in older groups make safer and more effective precautions to make the recommendations more effective.
WHO emergency use list
The Emergency Response Program (EULOGY) assesses the suitability of the novel health products during public emergencies. The aim is to make medicines, medications and diagnoses more readily available to deal with emergencies, while adhering to strict standards of safety, efficacy and quality. Tests measure the risk posed by an emergency and the potential benefits of using the product in any potential risk.
The EULOGY method includes a complex phase II evaluation and a phase VIII clinical trial data with additional details of safety, efficacy, quality and risk management plan. This information is reviewed by independent experts and the WHO team looking at current evidence of the vaccine being studied, as well as its monitoring programs, and other research programs.
As part of the EULOGY process, the vaccination company must commit itself to continuing to provide full license details and verification of WHO vaccine terms. The WHO appointment process will review additional clinical data from ongoing clinical trials and distribution to ensure that the vaccine meets the required standards of quality, safety and efficacy in a comprehensive manner.
WHO also launched the Pfizer / biotech vaccine for emergency use on 31 December 2020; two Astra enema / Oxford COVID-19 drugs dated 15 February 2021, developed by Astra enemas KBO (Republic of Korea) and the Serum Institute of India; and the COVID-19 vaccine developed by Jansen (Johnson & Johnson) on 12 March 2021. SAGE is a major group advising the WHO on vaccines and vaccines. It is responsible for advising the WHO on global policies and strategies, from vaccination and technology, to research and development, for the delivery of vaccines and their integration and other health interventions. SAGE applies not only to vaccines and vaccines, but to all vaccines preventable diseases.
SAGE has issued recommendations on Pfizer (8 January 2021), Modern a (25 January 2021), Astra enema (21 April 2021), and the Jansen COVED vaccine (17 March 2021), and has released a road map and public roads.
SAGE and EULOGY are similar but independent processes. The EULOGY process focuses on determining whether a product made is guaranteed quality, safe and effective. SAGE is governed by policy. Vaccination policy recommendations only apply to vaccination campaigns where the product has been prescribed or approved for use.
In the context of COVID-19 and due to the urgent need for vaccines, the SAGE Secretariat and the EULER team were working together to allow the WHO EULOGY recommendations and policies, according to available evidence, to be issued in the same manner.