EU Regulator Backs Pfizer's BA.4/5-Adapted COVID Booster

A vial of the Pfizer-BioNTech coronavirus disease (COVID-19) booster vaccine targeting BA.4 and BA.5 Omicron sub variants is pictured at Skippack Pharmacy in Schwenksville, Pennsylvania, US, September 8, 2022. (Reuters)
A vial of the Pfizer-BioNTech coronavirus disease (COVID-19) booster vaccine targeting BA.4 and BA.5 Omicron sub variants is pictured at Skippack Pharmacy in Schwenksville, Pennsylvania, US, September 8, 2022. (Reuters)
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EU Regulator Backs Pfizer's BA.4/5-Adapted COVID Booster

A vial of the Pfizer-BioNTech coronavirus disease (COVID-19) booster vaccine targeting BA.4 and BA.5 Omicron sub variants is pictured at Skippack Pharmacy in Schwenksville, Pennsylvania, US, September 8, 2022. (Reuters)
A vial of the Pfizer-BioNTech coronavirus disease (COVID-19) booster vaccine targeting BA.4 and BA.5 Omicron sub variants is pictured at Skippack Pharmacy in Schwenksville, Pennsylvania, US, September 8, 2022. (Reuters)

The European Medicines Agency (EMA) on Monday recommended a COVID-19 booster designed to combat Omicron offshoots BA.4/5, days after endorsing a pair of boosters tailored to target the older BA.1 variant.

The latest recommendation is for a so-called bivalent vaccine developed by Pfizer and BioNTech, which targets BA.4/5 as well as the strain of the virus that originally emerged in China in December 2019.

The EMA recommendation is to authorize the vaccines for people aged 12 and above who have received at least primary vaccination against COVID. The final go-ahead will be subject to European Commission approval, which is expected to come shortly.

If authorized, the BA.4/5-tailored booster will be available in days to all 27 EU member states, Pfizer said in a statement on Monday.

While existing coronavirus vaccines provide good protection against hospitalization and death, their effectiveness was reduced as the virus evolved.

Earlier this month, the EMA endorsed both Pfizer-BioNTech and Moderna's BA.1 updated vaccines.

EU officials signaled in recent months they were open to initially using shots targeting the older BA.1 variant, given those specifically targeting newer Omicron offshoots BA.4/5 are further behind in development.

In contrast, the US Food and Drug Administration (FDA) insisted it was only interested in vaccines targeting BA.4/5. Last week, Pfizer-BioNTech and Moderna secured US approval for those.

Given BA.1 emerged first, data from human trials testing the adapted vaccines from sets of developers has been submitted to EU regulators. For the BA.4/5 adapted vaccines, regulatory submissions are largely based on lab and animal data.

Using animal and lab data to solicit regulatory approval for retooled vaccines is not without precedent - it is done regularly for flu vaccines that are revamped each year to combat new variants.

On Monday, the EMA said its backing of the Pfizer-BioNTech updated BA.4/5 shot relied partly on data from human clinical trials available on the companies' BA.1-tailored vaccine.

EU officials have encouraged member states to roll out boosters of the established original vaccines and the bivalent shots - whatever is readily available - this autumn/winter initially for the vulnerable and elderly, following a rise in infections over the summer as protection waned due to the domination of BA.4/BA.5.

But uptake of the updated vaccines could be limited, as people have become less worried about the disease, thanks in large part to the success of first generation of shots.



Blood Tests Allow 30-year Estimates of Women's Cardio Risks, New Study Says

A woman jogs in a park in Saint-Sebastien-sur-Loire near Nantes, France January 19, 2024. REUTERS/Stephane Mahe/File Photo Purchase Licensing Rights
A woman jogs in a park in Saint-Sebastien-sur-Loire near Nantes, France January 19, 2024. REUTERS/Stephane Mahe/File Photo Purchase Licensing Rights
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Blood Tests Allow 30-year Estimates of Women's Cardio Risks, New Study Says

A woman jogs in a park in Saint-Sebastien-sur-Loire near Nantes, France January 19, 2024. REUTERS/Stephane Mahe/File Photo Purchase Licensing Rights
A woman jogs in a park in Saint-Sebastien-sur-Loire near Nantes, France January 19, 2024. REUTERS/Stephane Mahe/File Photo Purchase Licensing Rights

Women’s heart disease risks and their need to start taking preventive medications should be evaluated when they are in their 30s rather than well after menopause as is now the practice, said researchers who published a study on Saturday.

Presenting the findings at the European Society of Cardiology annual meeting in London, they said the study showed for the first time that simple blood tests make it possible to estimate a woman’s risk of cardiovascular disease over the next three decades.

"This is good for patients first and foremost, but it is also important information for (manufacturers of) cholesterol lowering drugs, anti-inflammatory drugs, and lipoprotein(a)lowering drugs - the implications for therapy are broad," said study leader Dr. Paul Ridker of Brigham and Women’s Hospital in Boston, Reuters reported.

Current guidelines “suggest to physicians that women should generally not be considered for preventive therapies until their 60s and 70s. These new data... clearly demonstrate that our guidelines need to change,” Ridker said. “We must move beyond discussions of 5 or 10 year risk."

The 27,939 participants in the long-term Women’s Health Initiative study had blood tests between 1992 and 1995 for low density lipoprotein cholesterol (LDL-C or “bad cholesterol”), which are already a part of routine care.

They also had tests for high-sensitivity C-reactive protein (hsCRP) - a marker of blood vessel inflammation - and lipoprotein(a), a genetically determined type of fat.

Compared to risks in women with the lowest levels of each marker, risks for major cardiovascular events like heart attacks or strokes over the next 30 years were 36% higher in women with the highest levels of LDL-C, 70% higher in women with the highest levels of hsCRP, and 33% higher in those with the highest levels of lipoprotein(a).

Women in whom all three markers were in the highest range were 2.6 times more likely to have a major cardiovascular event and 3.7 times more likely to have a stroke over the next three decades, according to a report of the study in The New England Journal of Medicine published to coincide with the presentation at the meeting.

“The three biomarkers are fully independent of each other and tell us about different biologic issues each individual woman faces,” Ridker said.

“The therapies we might use in response to an elevation in each biomarker are markedly different, and physicians can now specifically target the individual person’s biologic problem.”

While drugs that lower LDL-C and hsCRP are widely available - including statins and certain pills for high blood pressure and heart failure - drugs that reduce lipoprotein(a) levels are still in development by companies, including Novartis , Amgen , Eli Lilly and London-based Silence Therapeutics.

In some cases, lifestyle changes such as exercising and quitting smoking can be helpful.

Most of the women in the study were white Americans, but the findings would likely “have even greater impact among Black and Hispanic women for whom there is even a higher prevalence of undetected and untreated inflammation,” Ridker said.

“This is a global problem,” he added. “We need universal screening for hsCRP ... and for lipoprotein(a), just as we already have universal screening for cholesterol.”