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BioNTech expects pre-reserved vaccine bottling capacity to be freed up

By Ludwig Burger

FRANKFURT (Reuters) – BioNTech said global capacity to bottle new COVID-19 vaccines, which is in tight supply as producers hoping to develop successful candidates book up slots, will likely be more freely available once some drop out of the race.

“If clinical trials fail or get delayed, capacity may be freed up again,” Sierk Poetting, BioNTech’s head of operations and finance, told an online news conference on Thursday.

“The (fill and finish) market is indeed very tight because everyone has reserved capacity, but I believe we will see some adjustments there once the first products are on the market,” he said.

“This is certainly a type of capacity that can be more easily transferred (than production capacity).”

More than 40 experimental vaccines are currently being tested on volunteers around the globe to combat the new coronavirus, which has claimed more than 1 million lives.

Also speaking at the briefing, German research minister Anja Karliczek reiterated a prediction that it would likely take until mid-2021 for a vaccine to be available to the overall population, as production ramp-ups would take some time.

BioNTech and its partner Pfizer have said that if they win approval for their vaccine candidate, they aim to supply up to 100 million doses worldwide by the end of 2020 and a further 1.3 billion by the end of 2021.

(Additional reporting by Thomas Escritt; Editing by Maria Sheahan and Jan Harvey)

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U.S. expects over 1 million COVID-19 antibody doses from Regeneron, Lilly in 2020

By Michael Erman and Manas Mishra

NEW YORK (Reuters) – The U.S. government expects to be able to provide at no cost more than 1 million doses of antibody treatments for COVID-19 similar to the one President Donald Trump received to treat his illness, according to a top U.S. health official on Friday.

The government’s Operation Warp Speed program currently has “a couple of hundred thousand doses” of the monoclonal antibody treatments being developed by drugmakers Regeneron Pharmaceutical Inc <REGN.O> and Eli Lilly & Co <LLY.N>, U.S. Department of Health and Human Services official Paul Mango said on a call with reporters. That would top 1 million doses by the end of the year, he said.

Trump received Regeneron’s treatment last week. In a radio interview with Rush Limbaugh on Friday, Trump said he is working to get both drugs approved quickly and that he may not have recovered without the treatments he received.

Both companies have said the drugs were shown to work in clinical trials and that they have submitted an emergency use authorization to the U.S. Food and Drug Administration (FDA).

The drugs are not identical: Regeneron’s treatment is a cocktail of two antibodies meant to protect against the virus, while Lilly’s is a single antibody. Because they have not been tested against the other, it is difficult to know if one is more effective than the other.

It is unclear how long the FDA process to authorize emergency use of the drugs will take. Unless the companies receive that authorization, doctors cannot administer the drugs to patients outside of clinical trials or without a compassionate use authorization like the one President Trump received.

If the drugs are authorized for use by the FDA, Mango said that the government will allocate the treatments to the states based on need, similar to the mechanism used with Gilead Sciences Inc’s <GILD.O> antiviral drug remdesivir for COVID-19.

Regeneron signed a $450 million deal in July to sell Operation Warp Speed enough doses of its antibody treatment, REGN-COV2, to treat around 300,000 people.

The company said it has not signed any additional deals with Operation Warp Speed, and has around 50,000 doses of its treatment ready now.

Lilly said on Friday it has not signed an agreement with Operation Warp Speed. It said earlier this week that it expects to produce around one million doses of the treatment this year.

(Reporting by Manas Mishra in Bengalaru and Michael Erman in New York; writing by Caroline Humer; Editing by Chizu Nomiyama, Aurora Ellis and Kirsten Donovan)

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U.S. vaccine program head Slaoui expects Pfizer, Moderna vaccine data readouts in November-December

(Reuters) – The chief adviser for the U.S. government’s Operation Warp Speed COVID-19 vaccine program, Moncef Slaoui, on Tuesday said efficacy data readouts are expected from Pfizer Inc and Moderna Inc between next month and December.

a man wearing a suit and tie: U.S. President Trump holds coronavirus response event in the Rose Garden at the White House in Washington

© Reuters/Kevin Lamarque
U.S. President Trump holds coronavirus response event in the Rose Garden at the White House in Washington

Speaking at a symposium conducted by the Johns Hopkins University and the University of Washington, Slaoui said data readouts from leading vaccine developers are expected to come in three waves over the next several months.

The first wave would be coming from Pfizer and Moderna, both of which are developing mRNA-based vaccines for the coronavirus, he said.

Slaoui said efficacy data on one or two vaccines will be available within the next month or two, for which there will be enough doses to immunize 30 million people between November and December.

Commenting on AstraZeneca’s vaccine program, Slaoui said while the company’s U.S. study remains on hold, data readouts on the vaccine’s effectiveness may be expected somewhere in late October or November from ongoing studies in the UK, Brazil and South Africa.

“At that time, we will have very few doses to be able to, if the decision was to approve the vaccine, immunize,” he said, adding that efforts are in place to scale up manufacturing and stockpiling of the vaccine.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Andrea Ricci)

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