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The United States has taken one step closer to obtaining its first COVID-19 vaccine, BioNTech (BNTX) – Pfizer’s development partner (PFE) – is expected to apply for emergency use authorization .
With the coronavirus crisis reaching a crescendo around the world, CEO Ugur Sahin told CNN on Wednesday that the company planned to file on Friday, which the US Health and Human Services Sec. Alex Azar reiterated during the White House Coronavirus Task Force briefing on Thursday. Steps towards approving and distributing a COVID-19 inoculation have become increasingly urgent, with hospitalizations in the United States and new infections reaching new heights in recent days.
BioNTech’s move comes just days after the two companies announced that their two-dose vaccine was 95% effective against the coronavirus and that they planned to file for regulatory approval “within days” .
While the data to support this statement has yet to be released, health officials are cautiously optimistic. Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said vaccine effectiveness is one thing – but real-world effectiveness is another.
“If you like highly effective vaccines over the years, they’ve crushed dreaded epidemics like smallpox, like polio, like measles,” Fauci said – calling the 95% threshold “extraordinary”.
Still, concerns remain about the ease of distributing the BioNTech / Pfizer vaccine, along with other candidates that may also soon be authorized, to reach the far corners of the country.
President-elect Joe Biden noted that the decision of Operation Warp Speed - the Trump administration’s initiative to fund and produce national candidate vaccines – to partner with Walgreens (WBA) and CVS (CVS ) was not ideal for reaching rural residents and some communities of Color.
“So we have to make sure there is access for them,” Biden said at a press briefing Thursday.
Rural access to a vaccine – and significantly lower volume demands that could affect prioritization – is a concern voiced by the president of Amerisource Bergen’s Good Neighbor Pharmacy.
But Warp Speed officials said on Wednesday there were already plans to help support areas that need an ultra-cold freezer or other support. General Gustave Perna said on Thursday that there were already 100 million vaccine kits ready to ship, along with the vaccines, 24 hours after an emergency use authorization was granted.
Brandon Daniels, president of global markets at consulting firm Exiger, said that now that the vaccine’s effectiveness was known, the effectiveness of the supply chain was being tested.
“Now we are seeing cryogenic companies and packaging companies starting to become bigger names in the supply chain,” Daniels said.
It is possible that the coronavirus mass testing infrastructure, created to help reach hard-to-reach communities, could also play a key role in vaccine distribution, he added.
Meanwhile, states are already preparing to receive the first shipment of vaccines in mid-December, with hopes that frontline health workers and nursing homes will be high on the priority list.
WHO rejects remdesivir
A panel of World Health Organization doctors said they did not recommend Gilead Science’s antiviral remdesivir (GILD), marketed as Veklury, to treat Covid-19, in a British Medical Journal (BMJ) article Thursday evening.
Based on recent results from WHO trials of Veklury and other proposed treatment options for coronaviruses, doctors say there was not enough to support use.
The article “contains a weak or conditional recommendation against the use of remdesivir in hospitalized patients with Covid-19,” the doctors said.
Gilead said in a response he was disappointed with the decision, given that the United States and other countries like Germany, Japan and the United Kingdom have approved the drug for use in hospital patients. .
Gilead told me.
In early October, Geoffery Porges, analyst at SVB Leerink, said that based on all the trial results, “remdesivir looks a lot like it was in its earlier trials and in its interim disclosure – moderately effective in patients. at the ideal point for treatment. “
While this is “absolutely not a wonder drug,” Porges noted that it is likely to be used in combination with monoclonal antibodies “in countries and institutions that can afford the cost and can make diagnostic decisions. complex about the people to be treated. “
With a price tag of over $ 3,000, remdesivir and monoclonal antibodies are expensive treatment options, compared to more cost-effective and clinically effective corticosteroids like dexamethasone which are widely used in the treatment of patients with Covid-19.
“Particularly considering the costs and resource implications associated with remdesivir, but consistent with the approach that should be taken with any new drug, the expert group felt that the onus should be to demonstrate efficacy. , which is not established by the currently available data, ”The WHO doctors said.
In a separate move, the United States Food and Drug Administration has cleared the treatment of Eli Lilly’s rheumatoid arthritis in combination with remdeisvir for emergency use.
Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research, said the clearance comes as the need for more treatment options grows.
“Despite the progress made in managing COVID-19 infection since the onset of the pandemic, we need more therapies to speed recovery, and further clinical research will be essential to identify therapies that slow the progression. disease and reduce mortality in sicker patients, ”Cavazzoni told me.
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