NEW YORK: Moderna could have a COVID-19 booster shot targeting the omicron variant tested and ready to file for US authorization as soon as March, the company’s president said on Wednesday.
Moderna President Stephen Hoge said he believes booster shots carrying genes specifically targeting mutations in the newly-discovered omicron variant would be the quickest way to address any anticipated reductions in vaccine efficacy it may cause.
“We’ve already started that program,” he said.
The company is also working on a multi-valent vaccine that would include up to four different coronavirus variants including omicron.
That could take several more months, he said.
The United States identified its first COVID-19 case caused by the omicron variant in California, the US Centers for Disease Control and Prevention said on Wednesday.
Omicron, dubbed a “variant of concern” by the World Health Organization, is being studied to see if it is more contagious or causes more severe illness than other variants, and if it can evade current vaccines.
Given prior guidance from the US Food and Drug Administration, which has required mid-stage clinical testing, Hoge said the process could take three or four months.
“The omicron-specific boosters, just realistically, are not before March and maybe more in the second quarter,” Hoge said, unless the FDA changes its guidance for what data would be needed for authorization.
Moderna would be able to manufacture the vaccine as it was conducting the testing, Hoge said, to have it ready to roll out as soon as possible.
He said the FDA is currently assessing the threat to vaccine protection posed by the omicron variant. The agency could provide a faster timeline, akin to the way it approves vaccines for influenza, by approving changes in the flu strains, which would shorten the three- to four-month timeline.
In the United States, licensed flu vaccines can be updated each season by substituting in new strains of the virus that are believed to be most likely to cause illness in the upcoming flu season, without the need for large, randomized clinical trials.
Based on the pattern of mutations seen in the omicron variant, which include mutations that have already been shown to reduce the efficacy of its vaccine in lab studies, Hoge said, “we expect there will be an impact.”
It is not clear yet how big of a drop in efficacy the omicron variant will cause for current vaccines, but it could be significant, Hoge surmised.
“The mutations that had previously led to the biggest drops in efficacy were seen in Delta and Beta. And all of those mutations have shown up in omicron,” Hoge said.
“And so the question here is, are we going to see a Delta-like performance? Are we going to see a Beta-like performance? Or are we going to see some cross multiple of the two? I think it’s that last scenario that has people most concerned,” he said.
Hoge said the company is testing to see whether fully vaccinated recipients of Moderna’s vaccine are protected against the variant, as well as those who received the 50-microgram and 100-microgram booster doses of the shot.
“I still believe that the existing vaccines will be able to at least slow down, if not completely stop, the omicron variant,” he said.
Moderna exec says company could have omicron booster ready in March
https://arab.news/5efkc
Moderna exec says company could have omicron booster ready in March
Two high-speed trains derail in Spain, broadcaster reports seven people killed
- The accident happened near Adamuz, which is near Cordoba
MADRID: Two high-speed trains derailed on Sunday in southern Spain, the rail network operator said, and state-run television channel RTVE said seven people had died, citing police sources.
The accident happened near Adamuz, in Cordoba province. Seven people have been confirmed dead by police, RTVE said, adding that 100 people have been injured, 25 seriously.
Spanish police did not immediately respond to request for comment from Reuters.
“The Iryo 6189 Malaga — (to Madrid) train has derailed from the track at Adamuz, crashing onto the adjacent track. The (Madrid) to Huelva train which was traveling on the adjacent track has also derailed,” said Adif, which runs the rail network, in a social media post.
Adif said the accident happened at 6:40 p.m. (1740 GMT), about ten minutes after the Iryo train left Cordoba heading toward Madrid.
Iryo is a private rail operator, majority-owned by Italian state-controlled railway group Ferrovie dello Stato. The train involved was a Freccia 1000 train which was traveling between Malaga and Madrid, a spokesperson for Ferrovie dello Stato said.
Iryo did not immediately respond to a request for comment.
Adif has suspended all rail services between Madrid and Andalusia.
Andalusia emergency services said on social media that all rail traffic had been halted and emergency services were on their way, including at least nine ambulances and emergency support vehicles.
CALLS FOR MEDICS
A woman named Carmen posted on X that she had been on board the Iryo to Madrid. “Ten minutes after departing (from Cordoba) the train started to shake a lot, and it derailed from coach 6 behind us. The lights went out.”
Footage posted by another Iryo train passenger, also on X, showed an Iryo staffer in a fluorescent jacket instructing passengers to remain in their seats in the darkened carriages, and those with first aid training to keep watch over fellow passengers.
The staffer told passengers they would be evacuated when it was safe to leave, but at that moment the safest place was on the train. He also urged people to maintain mobile phone batteries to be able to use their torches when they disembarked.
The passenger wrote: “In our carriage we’re well but we don’t know about the other carriages. There’s smoke and they’re calling for a doctor.”
The regional government has activated emergency protocols to mobilize more resources to the accident site. Locals posted on social media that a building would be set up in the village nearest the crash for evacuated passengers to be taken to.
Salvador Jimenez, a journalist for RTVE who was on board the Iryo train, shared images showing the nose of the rear carriage of the train lying on its side, with evacuated passengers sitting on the side of the carriage facing upwards.
Jimenez told TVE by phone from beside the stricken trains that passengers had used emergency hammers to smash the windows and climb out, and they had seen two people taken out of the overturned carriages on stretchers.
“There’s a certain uncertainty about when we’ll get to Madrid, where we’ll spend the night, we’ve had no message from the train company yet,” he said. “It’s very cold but here we are.”
