POST Online Media Lite Edition


NEWLY REPORTED COVID-19 CASES IN LAST 24 HOURS (8.3.2021, 5:30pm CEST, WHO):   U.S. 15,081    India 30,549    Brazil 20,503    Russia 22,010    France 1,996    The United Kingdom 21,687    Turkey 22,898    Argentina 6,083    Columbia 9,094    Spain 4,954    Italy 3,185    Iran 37,189    Germany 1,766    Indonesia 33,900    Mexico 6,740    South Africa 5,574    Peru 1,808    The Netherlands 2,136    Iraq 12,734    Philippines 8,167    Bangladesh 15,776    Malaysia 15,764    Pakistan 4,858    Portugal 1,190    Japan 8,877    Israel 1,326    Nepal 2,448    United Arab Emirates 1,537    Thailand 18,901    Morocco 4,206    Tunisia 1,243    Saudi Arabia 1,063    Georgia 4,827    Cuba 9,279    Myanmar 4,713    Ireland 1,352    Libya 2,892    South Korea 1,202    Algeria 1,358    Mongolia 1,019    Vietnam 7,832    Mozambique 1,421    Zimbabwe 1,309    Ghana 1,975    Réunion 3,014    Fiji 1,100    China 107    Singapore 111    New Zealand 1    Australia 229   

International regulators work on second-generation COVID-19 vaccines

Christian Fernsby |
Regulatory convergence is critical for expediting and streamlining global development and authorisation of new or modified COVID-19 vaccines to address emerging coronavirus variants.

Article continues below

The important role of regulatory alignment is described in the summary of the second workshop on COVID-19 vaccine development and virus variants, organised under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA).

COVID-19 variants have been emerging since March 2020, steadily spreading already before the start of the vaccination campaigns in Europe and abroad.

In light of continued mutations and new variants emerging globally, medicines regulators from around the globe have stressed the urgent public health priority to streamline regulatory processes and requirements for the development of new and adaptations of already-approved vaccines to protect against current or future strains.

Workshop participants discussed key regulatory considerations related to the development of second-generation COVID-19 vaccines and booster doses.

In particular, they exchanged views on the use of immunobridging (i.e. an approach to infer the likelihood of a vaccine’s protective effect) in the assessment of second-generation COVID-19 vaccines, the design and use of controlled clinical trials (placebo or other controls), and correlates of immunity (i.e. levels of a specific immune marker that indicates optimal protection has been achieved) for vaccines against COVID-19.

They also highlighted challenges and issues, such as authorisation of second-generation vaccines and alternative approaches to demonstrate vaccine efficacy, where alignment between regulators is needed to respond to the emerging COVID-19 virus variants.

The virtual workshop took place on 24 June 2021. It built on the experience and knowledge gained from the first workshop on COVID-19 vaccine development and virus variants held in February 2021, which underlined the need for robust data that would help to swiftly approve updated versions of available vaccines against the emerging strains.

The second workshop brought together delegates from more than 20 countries, representing 30 medicines regulatory authorities globally and the World Health Organization to exchange information about the global efforts towards developing modified and new vaccines against current and emerging variants.

The meeting was co-chaired by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

What to read next

How lying anti-vaccine doctor put millions of people in danger
France makes 11 child vaccines compulsory
Experimental Ebola vaccines elicit year-long immune response