Moderna's COVID-19 vaccine won't be ready by US election: report
WASHINGTON, United States — US biotech firm Moderna won't seek an emergency use authorization for its coronavirus vaccine before November 25, its CEO told the Financial Times on Wednesday.
The news deals a blow to President Donald Trump's hopes of having an injection ready before the election to give his campaign a much-needed boost.
Stephane Bancel told the newspaper: "November 25 is the time we will have enough safety data to be able to put into an EUA file that we would send to the FDA (Food and Drug Administration) — assuming that the safety data is good, i.e. a vaccine is deemed to be safe."
Trump, whose approval has taken a hit over his handling of the COVID-19 crisis, has frequently hinted a vaccine could be ready before the November 3 vote.
This has raised concern among experts that his administration may attempt to interfere with the regulatory process for political reasons.
The Republican repeated his claim on Tuesday night, during a debate with his Democratic rival, former vice president Joe Biden.
"It's a possibility that we'll have the answer before November 1," he said.
Moderna's vaccine is one of 11 experimental vaccines in final stage trials.
Another is being developed by Pfizer, whose CEO Albert Bourla has taken the position that his company may have a clear answer about whether their shot works by October.
Most experts are skeptical of the claim, believing that the ongoing trials will not have sufficient statistical data to prove the drug's safety and effectiveness by that time.
Speaking to the Washington Post on Tuesday, Bourla denied he was attempting to curry favor with the president by making his October claim.
"For me, the election day is an artificial day. The end of October is an artificial day. This is how we operate. If we can bring it earlier, we will," he said.
Pharma giants Sanofi and GSK said on July 29, 2020, that they have agreed to supply Britain with up to 60 million doses of a potential COVID-19 vaccine. The agreement covers a vaccine candidate developed by France's Sanofi in partnership with the UK's GSK and is subject to a "final contract."
This thread collects some of the major developments in the search for a vaccine to ease the new coronavirus pandemic. (Main photo by AFP/Joel Saget)
As negotiations towards a new pandemic treaty pick up pace, observers warn of watered-down efforts to ensure equitable access to the medical products needed to battle future Covid-like threats.
Shaken by the pandemic, the World Health Organization's 194 member states are negotiating an international accord aimed at ensuring countries are better equipped to deal with the next catastrophe, or even prevent it altogether.
The process is still in the early stages, with the aim of reaching an agreement by May 2024.
But critics warn that revisions being made to the preliminary negotiating text are weakening the language -- notably in a key area aimed at preventing the rampant inequity seen in access to vaccines and other medical products during the Covid pandemic.
"I think it is a real step backwards," Suerie Moon, co-director of the Global Health Centre at the Geneva Graduate Institute, told AFP. — AFP
Africa's first mRNA vaccine hub is ceremonially launched on Thursday to acclaim from the UN's global health chief, who hailed it as a historic shift to help poor countries gain access to life-saving jabs.
The facility was set up in the South African city of Cape Town in 2021 on the back of the success of revolutionary anti-Covid vaccines introduced by Pfizer/BioNTech and Moderna.
"This precious project... will bring a paradigm shift in addressing the serious problem we faced, the equity problem, during the pandemic, so (that) it's not repeated again," World Health Organization (WHO) head Tedros Adhanom Ghebreyesus tells a media briefing to mark the inauguration. — AFP
China has approved its first locally developed messenger RNA (mRNA) vaccine against Covid-19, its manufacturer said Wednesday, months after the relaxation of strict Covid-zero regulations sparked a surge in cases.
The vaccine, developed by CSPC Pharmaceutical Group Ltd, has been approved for "emergency use" by Beijing's health regulator, the company said in a statement.
It showed high efficacy in a trial in which it was used as a booster shot for people who have been given other types of vaccines, the company added, without offering further details. — AFP
COVID-19 vaccine maker Novavax raises doubts about its ability to continue its business, announcing plans to cut spending after struggles in rolling out its coronavirus jab.
Shares of Novavax plummeted 25 percent in extended trading, after the company reported fourth-quarter earnings that missed analyst estimates.
While the firm should have enough money to fund operations, the situation is "subject to significant uncertainty," it says in a statement. — AFP
The protection against Covid-19 from being previously infected lasts at least as long as that offered by vaccination, one of the largest studies conducted on the subject says.
Ten months after getting Covid, people still had an 88% lower risk of reinfection, hospitalisation and death, according to the study published in the Lancet journal.
That makes this natural immunity "at least as durable, if not more so" than two doses of Pfizer or Moderna's vaccines, the study says.
The authors nevertheless emphasized that their findings should not discourage vaccination, which remains the safest way to get immunity. — AFP
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