With cases of Omicron BA.4 and BA.5 soaring in Europe and around the world, the European Medicines Agency (EMA) recommends everyone 60 and older get a second COVID-19 booster shot.

EMA’s recommendation came shortly before WHO reconvened its COVID Emergency Committee on Friday to reconsider its global recommendations for the pandemic – and if the state of global health emergency first declared on 30 January 2020, should be maintained.  So far WHO recommendations on a second booster, provided by another expert group in May, are limited to immunocompromised people. 

Speaking at a press conference Thursday, EMA’s head of vaccines, Marco Cavaleri said a fourth booster for people over 60 and other vulnerable groups is now warranted due to a regional increase in COVID cases. 

He said projections show the BA.4 and BA.5 sub variants are expected to become dominant across all European countries, likely completely replacing all other variants by the end of July.

“As this new wave is unfolding over the EU, it is essential to maintain protection of vulnerable groups and avoid any postponement of vaccination,” Cavaleri said. “Although there is no evidence of increased infection severity in the BA.4 and BA.5 compared to other sub variants, the increased transmission among older age groups is starting to translate into severe disease.”

Globally, COVID-19 cases have increased by at least 30%, driven by variants BA.4 and BA.5 in Europe and the US, while a new sub-lineage of BA.2.75 is rising in India, WHO Director-General Dr Tedros Adhanom Ghebreyesus told a briefing on Wednesday. 

EMA and other regulators looking toward approval of “bivalent” COVID vaccines by September

While current vaccines offer “good protection” against hospitalization, severe disease and death, EMA and other regulatory agencies around the world are now looking closely at new “bivalent” COVID vaccine formulations, Cavaleri said.

EMA, the US Food and Drug Administration and other national regulatory authorities met last week under the auspices of the International Coalition of Regulatory Authorities (ICMRA) to examine available data on the new vaccines in light of the reduced protection that current vaccines offer against mild and moderate disease.

“Preliminary data from clinical trials indicate that adapted messenger RNA (mRNA) vaccines which incorporate an Omicron variant strain can increase and extend protection, when used as a booster,” Cavaleri said of ICMRA’s conclusions. “Bivalent mRNA vaccines which combine two strains of SARS-CoV-2, one of which is an Omicron strain … appear to offer an even wider immune response.”

But vaccines that include other variants or subvariants might also be considered for use as boosters, if clinical trial data demonstrate an adequate level of neutralization against Omicron and other variants of concern.

Cavaleri said his agency is evaluating initial data that mRNA vaccines manufacturers have submitted for review and is in close contact with manufacturers of vaccines based on different platforms other than mRNA, especially adjuvanted protein vaccines.

“Overall we expect to potentially have several vaccines to include … with an assortment of different platforms and technologies, and this is welcome,” he said.

EMA also is working towards approval of adapted COVID-19 vaccines in September, with an eye towards what Cavaleri described as “plans for an even broader rollout of vaccination campaigns in the autumn.”

Future Course of WHO Public Health Emergency Designation for COVID

WHO hasn’t changed its designation of COVID-19 as a pandemic, and it was not expected to do so at Friday’s COVID Emergency Committee meeting – although as of Sunday afternoon no statement by the Commitee had yet been made, raising questions about what directives might yet be issued.

Irregardless of current trends showing increased transmission in many parts of the world, there is growing acknowledgement that the COVID emergency is evolving into an endemic disease. 

That will likely mean further peaks and valleys, but be far less lethal than the initial waves of 2020. And sooner or later, that will prompt a re-evaluation of the status of COVID as a “Public Health Emergency of International Concern” (PHEIC), requiring countries to undertake special measures under the terms of International Health Regulations.  

At a press conference on Thursday, Dr Mike Ryan, WHO’s head of health emergencies, described it as more of “a series of national epidemics” and stressed the real work needed to take place “at the national level.”

In line with those trends, WHO and Gavi, the Vaccine Alliance acknowledged plans this week to “transition” the work of the Act Accelerator initiative for distributing COVID vaccines, tests and treatments into the work of key ACT-A partners and national health systems.  

Under the auspices of ACT-A, COVAX, the global vaccine facility has distributed hundreds of millions of doses of COVID vaccines to 92 low-income countries since March 2021 with the support of Gavi, UNICEF and WHO. Tthe vaccine facility was hampered early in the pandemic by severe vaccine supply shortages and later by widespread public uptake of vaccines as they became more available.

-Updated 10 July 2022

Image Credits: Flickr: IMF/ Raphael Alves.