ADVERTISEMENT
Africanian
  • News
  • Politics
  • Business
  • Health
  • Sports
  • Travel
  • World
    • US
    • Russia
    • Europe
    • Asia
    • America
No Result
View All Result
Africanian
No Result
View All Result
Home Health

WHO issues emergency use listing for eighth COVID-19 vaccine

The vaccine is formulated from an inactivated SARS-CoV-2 antigen and is presented in single dose vials and multidose vials of 5, 10 and 20 doses.

in Health
Reading Time: 3 mins read
0 0
0
WHO issues emergency use listing for eighth COVID-19 vaccine
0
SHARES
Share on FacebookShare on TwitterShare via Whatsapp

Today, the World Health Organization (WHO) issued an emergency use listing (EUL) for COVAXIN® (developed by Bharat Biotech), adding to a growing portfolio of vaccines validated by WHO for the prevention of COVID-19 caused by SARS-CoV-2.

WHO’s EUL procedure assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.

“This emergency use listing expands the availability of vaccines, the most effective medical tools we have to end the pandemic,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products. ‘But we must keep up the pressure to meet the needs of all populations, giving priority to the at-risk groups who are still waiting for their first dose, before we can start declaring victory.”

COVAXIN® was assessed under the WHO EUL procedure based on the review of data on quality, safety, efficacy, a risk management plan and programmatic suitability. The Technical Advisory Group (TAG), convened by WHO and made up of regulatory experts from around the world, has determined that the vaccine meets WHO standards for protection against COVID-19, that the benefit of the vaccine far outweighs risks and the vaccine can be used globally.

COVAXIN® was also reviewed on 5 October by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), which formulates vaccine specific policies and recommendations for vaccines’ use in populations (i.e. recommended age groups, intervals between doses, specific groups such as pregnant and lactating women).

More

LOS ANGELES: Experts warn US reaches critical moment with nearly 3,000 monkeypox cases

The 32nd batch of Chinese medical team to Equatorial Guinea arrived in Malabo

Africa battles COVID-19 and 11 other mostly zoonotic disease outbreaks — Africa CDC

The SAGE recommended use of the vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above. COVAXIN® was found to have 78% efficacy against COVID-19 of any severity, 14 or more days after the second dose, and is extremely suitable for low- and middle-income countries due to easy storage requirements.

Available data on vaccination of pregnant women with the vaccine are insufficient to assess vaccine safety or efficacy in pregnancy; studies in pregnant women are planned, including a pregnancy sub-study and a pregnancy registry.

WHO emergency use listing

The emergency use listing (EUL) 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. The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.

The EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data, as well as substantial additional data on safety, efficacy, quality and a risk management plan. These data are reviewed by independent experts and WHO teams who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and plans for further studies.

As part of the EUL process, the company producing the vaccine must commit to continue to generate data to enable full licensure and WHO prequalification of the vaccine. The WHO prequalification process will assess additional clinical data generated from vaccine trials and deployment on a rolling basis to ensure the vaccine meets the necessary standards of quality, safety and efficacy for broader availability.

See all EUL listings

SAGE

SAGE is the principal advisory group to WHO for vaccines and immunization. It is charged with advising WHO on overall global policies and strategies, ranging from vaccines and immunization technology, research and development, to delivery of immunization and its linkages with other health interventions. SAGE is concerned not just with childhood vaccines and immunization, but all vaccine-preventable diseases.

SAGE assesses evidence on safety, efficacy, effectiveness, impact and programmatic suitability, considering both individual and public health impact.  SAGE Interim recommendations for EUL products provide guidance for national vaccination policy makers.  These recommendations are updated as additional evidence becomes available and as there are changes to the epidemiology of disease and the availability of additional vaccines and other disease control interventions.

Source: WHO

africanian

africanian

Africanian, an Africa news media portal.

  • Trending
  • Comments
  • Latest
Equatorial Guinea: Ecobank Ready to Provide Services to NAHSCO

Equatorial Guinea: Ecobank Ready to Provide Services to NAHSCO

August 11, 2022
Dream Talks: Ecosystem Builder John Rexford Nzira Bets on Africa's Future

Dream Talks: Ecosystem Builder, John Rexford Nzira, Bets on Africa’s Future

August 12, 2022
"When two elephants fight, the one who suffers the most is the grass they step on." -- African Proverb

African Proverb: “When two elephants fight, the one who suffers the most is the grass they step on.”

February 24, 2022
Equatorial Guinea: Ecobank Ready to Provide Services to NAHSCO

Equatorial Guinea: Ecobank Ready to Provide Services to NAHSCO

August 11, 2022
AfroSports: Nigeria’s Gold Rush In The Commonwealth Games Set To Inspire The Next Generation

AfroSports: Nigeria’s Gold Rush In The Commonwealth Games Set To Inspire The Next Generation

August 10, 2022
Nigeria: Buhari Pledges Support For Global Cultural, Tourism Events

Nigeria: Buhari Pledges Support For Global Cultural, Tourism Events

August 10, 2022
Africanian

Copyright © 2022 Africanian.com.

Follow Us

No Result
View All Result
  • News
  • Politics
  • Business
  • Health
  • Sports
  • Entertainment
  • Tech
  • Travel
  • World

Copyright © 2022 Africanian.com.

Welcome Back!

Login to your account below

Forgotten Password? Sign Up

Create New Account!

Fill the forms below to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In

Log In

Sign In

Forgot password?

Don't have an account? Register

Forgot password?

Enter your account data and we will send you a link to reset your password.

Back to Login

Your password reset link appears to be invalid or expired.

Log in

Privacy Policy

Accept

Add to Collection

  • Public collection title

  • Private collection title

No Collections

Here you'll find all collections you've created before.