Month: September 2022

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

The latest recommendation is for a so-called bivalent vaccine developed by Pfizer PFE.N and BioNTech 22UAy.DE, which targets BA.4/5 as well as the strain of the virus that originally emerged in China in December 2019 targeted by earlier COVID vaccines.

The EMA recommendation is to authorize the retooled booster shots 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, particularly against infection, was reduced as the virus evolved.

Earlier this month, the EMA endorsed both Pfizer-BioNTech and Moderna’s MRNA.O vaccines updated for BA.1.

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

In contrast, the U.S. Food and Drug Administration insisted it was only interested in vaccines targeting BA.4/5. Last week, Pfizer-BioNTech and Moderna secured U.S. authorization for those despite limited available clinical data.

Given BA.1’s earlier emergence, data from human trials testing those redesigned vaccines has been submitted to EU regulators. For the BA.4/5 adapted vaccines, regulatory submissions are largely based on lab and animal studies.

Using animal and lab data to solicit regulatory approval is done regularly for flu vaccines that are revamped each year to combat the latest circulating strains.

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.

A clinical trial testing the Pfizer-BioNTech BA.4/5 vaccine in humans was initiated in early September, and data should be available later this autumn. Meanwhile, human trial data on Moderna’s BA.4/5 shot is expected by later this month or early October.

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

Uptake could be limited, as people have become less worried about the disease, thanks in large part to the success of the first generation of shots. Experts also worry that the public may be suffering from vaccine fatigue and less likely to seek the boosters, which could be a fourth or fifth COVID shot for some.

Source: Voice Of America

New York Gov. Kathy Hochul said Friday the state was stepping up its polio-fighting efforts as the virus that causes the life-threatening disease was detected in the wastewater of yet another county in the New York City area.

Health officials began checking for signs of the virus in sewage water after the first case of polio in the United States in nearly a decade was identified in July in Rockland County, which is north of the city. The latest detection involved a wastewater sample collected last month in Nassau County on Long Island, directly east of the city.

The sample is genetically linked to the polio case from Rockland and provides further evidence of expanding community spread, state health officials said. The poliovirus had previously been detected in wastewater in New York City and three counties to its north: Rockland, Orange and Sullivan.

Hochul declared a state disaster emergency that allows EMS workers, midwives and pharmacists to administer polio vaccines and allows doctors to issue standing orders for the vaccine. Data on immunizations will be used to focus vaccination efforts where they’re needed the most.

“On polio, we simply cannot roll the dice,” state Health Commissioner Dr. Mary T. Bassett said in a prepared statement. “If you or your child are unvaccinated or not up to date with vaccinations, the risk of paralytic disease is real. I urge New Yorkers to not accept any risk at all.”

Health officials said all unvaccinated New York residents — including children by 2 months of age, pregnant people and those who haven’t completed their vaccine series — should get immunized immediately. They also urged boosters for certain people, such as health care workers in affected areas who treat patients who might have polio.

The statewide polio vaccination rate is 79%, but the counties of Rockland, Orange and Sullivan had lower rates.

Officials have said that it is possible that hundreds of people in the state have gotten polio and don’t know it. Most people infected with polio have no symptoms but can still give the virus to others for days or weeks.

The lone confirmed case in New York involved an unidentified young adult who was unvaccinated.

Source: Voice of America

A global search for alternative sources to Russian energy in light of the war in Ukraine has refocused attention on smaller, easier-to-build nuclear power stations, which proponents say could provide a cheaper, more efficient alternative to older model mega-plants.

U.K.-based Rolls-Royce SMR says its small modular reactors, or SMRs, are much cheaper and quicker to get running than standard plants, delivering the kind of energy security that many nations are seeking. France already relies on nuclear power for a majority of its electricity, and Germany kept the option of reactivating two nuclear plants it will shut down at the end of the year as Russia cuts natural gas supplies.

While Rolls-Royce SMR and its competitors have signed deals with countries from Britain to Poland to start building the stations, they are many years away from operating and cannot solve the energy crisis now hitting Europe.

Nuclear power also poses risks, including disposing of highly radioactive waste and keeping that technology out of the hands of rogue countries or nefarious groups that may pursue a nuclear weapons program.

Those risks have been accentuated following the shelling around Europe’s largest nuclear power plant in Zaporizhzhia, Ukraine, which has raised fears of potential nuclear disaster.

In the wake of the war, however, “the reliance on gas imports and Russian energy sources has focused people’s minds on energy security,” Rolls-Royce SMR spokesman Dan Gould said.

An SMR’s components can be built in a factory, moved to a site in tractor trailers and assembled there, making the technology more attractive to frugal buyers, he said.

“It’s like building Lego,” Gould said. “Building on a smaller scale reduces risks and makes it a more investible project.”

SMRs are essentially pressurized water reactors identical to some 400 reactors worldwide. The key advantages are their size — about one-tenth as big as a standard reactor — the ease of construction and the price tag.

The estimated cost of a Rolls-Royce SMR is $2.5 billion to $3.2 billion, with an estimated construction time of 5 1/2 years. That’s two years faster than it took to build a standard nuclear plant between 2016 and 2021, according to International Atomic Energy Agency statistics. Some estimates put the cost of building a 1,100-megawatt nuclear plant at between $6 billion and $9 billion.

Rolls-Royce aims to build its first stations in the U.K. within 5 1/2 years, Gould said. Similarly, Oklahoma-based NuScale Power signed agreements last year with two Polish companies — copper and silver producer KGHM and energy producer UNIMOT — to explore the possibility of building SMRs to power heavy industry. Poland wants to switch from polluting, coal-powered electricity generation.

Rolls-Royce SMR said last month that it signed a deal with Dutch development company ULC-Energy to look into setting up SMRs in the Netherlands.

Another partner is Turkey, where Russia is building the Akkuyu nuclear power plant on the southern coast. Environmentalists say the region is seismically active and could be a target for terrorists.

The introduction of “unproven” nuclear power technology in the form of SMRs doesn’t sit well with environmentalists, who argue that proliferation of small reactors will exacerbate the problem of how to dispose of highly radioactive nuclear waste.

“Unfortunately, Turkey is governed by an incompetent administration that has turned it into a ‘test bed’ for corporations,” said Koray Dogan Urbarli, a spokesman for Turkey’s Green Party.

“It is giving up the sovereignty of a certain region for at least 100 years for Russia to build a nuclear power plant. This incompetence and lobbying power make Turkey an easy target for SMRs,” said Koray, adding that his party eschews technology with an “uncertain future.”

Gould said one Rolls-Royce SMR would generate nuclear waste the size of a “tennis court piled 1-meter high” throughout the plant’s 60-year lifetime. He said initially, waste would be stored on site at the U.K. plants and would eventually be transferred to a long-term disposal site selected by the British government.

M.V. Ramana, professor of public policy and global affairs at the University of British Columbia, cites research suggesting there’s “no demonstrated way” to ensure nuclear waste stored in what authorities consider to be secure sites won’t escape in the future.

The constant heat generated by the waste could alter rock formations where it’s stored and allow water seepage, while future mining activities could compromise a nuclear waste site’s integrity, said Ramana, who specializes in international security and nuclear energy.

Skeptics also raise the risks of possibly exporting such technology in politically tumultuous regions. Gould said Rolls-Royce is “completely compliant” with U.K. and international requirements in exporting its SMR technology “only in territories that are signatories to the necessary international treaties for the peaceful use of nuclear power for energy generation.”

Ramana said, however, there’s no guarantee nations will follow the rules.

“Any country acquiring nuclear reactors automatically enhances its capacity to make nuclear weapons,” he said, adding that every SMR could produce “around 10 bombs worth of plutonium each year.”

Rolls-Royce SMR could opt to stop supplying fuel and other services to anyone flouting the rules, but “should any country choose to do so, it can simply tell the International Atomic Energy Agency to stop inspections, as Iran has done, for example,” Ramana said.

Although spent fuel normally undergoes chemical reprocessing to generate the kind of plutonium used in nuclear weapons, Ramana said such reprocessing technology is widely known and that a very sophisticated reprocessing plant isn’t required to produce the amount of plutonium needed for weapons.

Source: Voice of America