A week after reading out long-awaited interim Phase III results from their Covid-19 vaccine trial, Pfizer and BioNTech are talking distribution.
The vaccine, which Pfizer and BioNTech said is more than 90% effective at preventing symptomatic Covid-19, must be shipped in -70 degrees Celsius (-94 degrees Fahrenheit) temperatures to remain stable, then used within 5 days of being thawed. Delivery poses a major challenge, with some countries saying they can’t afford to build the distribution system required to handle the vaccine.
To test the waters, Pfizer has launched a pilot delivery program in Rhode Island, Texas, New Mexico and Tennessee, according to Reuters. The four states were chosen for their differences in size, diversity of populations, infrastructure, and urban and rural settings, the news agency reported.
“We are hopeful that results from this vaccine delivery pilot will serve as the model for other U.S. states and international governments, as they prepare to implement effective COVID-19 vaccine programs,” Pfizer said, per Reuters.
The pilot states won’t get doses earlier than other states or have special consideration, according to Pfizer. The pharma said it plans on filing for an EUA around the third week of November, once it has the necessary safety data to approach regulators.
Ding Sheng, director of the Beijing-based Global Health Drug Discovery Institute, told Bloomberg that production of Pfizer and BioNTech’s candidate is “costly” and requires cold-chain transportation. Philippines’ health secretary Francisco Duque told Reuters that the cold chain requirement is “hefty,” and that the country does “not have such facility.”
Pfizer has designed that “thermal shippers” can be stored at room temperature and keep the vaccine cold for 10 days if replenished with dry ice, which they say will
The US struck a $1.95 billion deal for 100 million doses of Pfizer and BioNTech’s vaccine, with the option to acquire another 500 million down the road. Last week, the drug makers finalized a deal with the EU for 200 million doses, with the option for 100 million more later on, though the parties didn’t disclose the cost.
Moderna said its candidate — which interim results have shown to be 94.5% effective — can be kept for months at -20 degrees Celsius (-4 Fahrenheit) and at refrigerator temperatures for up to 30 days. — Nicole DeFeudis
Eli Lilly teams with Samsung Biologics to mass produce its Covid-19 antibody
Beleaguered by questions about how safely it can make its Covid-19 neutralizing antibody, Eli Lilly has pulled out a card they placed at the beginning of the pandemic.
Samsung Biologics disclosed yesterday that they signed an agreement back in May to mass-produce its antibody and, after delays in securing raw materials, had recently begun production, Reuters reported.
The FDA recently authorized the antibody, known as bamlanivimab, for moderate and mild cases of Covid-19 — a huge population at a time when the US is recording 100,000 cases.
Experts such as ex-FDA chief Scott Gottlieb have warned for months that the US was under-investing in the infrastructure to mass produce the monoclonal antibodies in development at Lilly, Regeneron and elsewhere.
Lilly has said they can make 1 million doses by the end of this year, with 300,000 of those earmarked for the US. But they’ve been dogged by quality control questions at one of the plants churning out the drug. Although they authorized the antibody earlier this month, the FDA stipulated that Lilly would have to hire outside consultants to test batches and confirm the quality control data.
It was not immediately clear whether the Samsung production was baked into previous dose estimates from Lilly or would add new capacity. The Big Pharma has talked about ramping up production next year as new plants came online. In September, they announced a manufacturing collaboration with Amgen.
Lilly’s Covid-19 antibody will not be the first Samsung has agreed to help mass produce. The South Korean company has also signed agreements with Vir Biotechnology to produce the neutralizing antibody they are co-developing with GlaxoSmithKline. — Jason Mast
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