Covid-19 roundup: EU begins reviewing Moderna vaccine; CureVac and EU agree to 405M-dose deal
A day after announcing their vaccine is highly effective at preventing Covid-19, Moderna said European regulators have begun a rolling review of the product for approval.
The news sets Moderna’s mRNA-1273 vaccine to be one of the first Covid-19 vaccines authorized on both sides of the Atlantic, with CEO Stéphane Bancel anticipating in an interview Sunday that the FDA will OK both their vaccine and the vaccine co-developed by Pfizer and BioNTech in early or mid-December. Neither company has yet submitted to the US agency.
Although the second company to release pivotal data on a vaccine, Moderna is the third to begin a rolling review at the EMA. AstraZeneca and BioNTech, both based in Europe, announced in early October that regulators have begun a rolling review of the vaccine. Moderna said they submitted documents on Oct 14.
Designed to speed approvals, rolling reviews give the EMA an early look at certain preclinical, clinical and manufacturing data, but the agency doesn’t issue decisions until pivotal results are in. AstraZeneca is hoping to release such data before the end of the year, which would likely position them as the third Covid-19 vaccine company to do so.
It’s unclear how long the EMA may take to review a vaccine. The EMA has operated throughout the pandemic more deliberately than their American counterpart. The FDA, for example, authorized remdesivir three days after Phase III results came out and nearly two months before the EMA did.
EMA officials, though, indicated last month that they would have been willing to authorize a vaccine that’s less than 50% effective, the FDA’s bar. Both Pfizer and Moderna say their vaccines are more than 90% effective.
Bancel said Sunday he anticipated an FDA advisory hearing on their vaccine on Dec 7 or Dec 14, with an EUA coming a few days later. He predicted a similar timeline for Pfizer-BioNTech, with the two vaccines potentially sharing a single adcomm.
– Jason Mast
CureVac and EU agree to 405 million-dose deal
Moderna and Pfizer/BioNTech were the first companies to show pivotal data for their vaccines, but the third major mRNA company, CureVac, is looking to become the arsenal of Europe.
Already financed with a €300 million investment from the German government and a €75 million loan from the European Investment Bank, CureVac announced yesterday that they have signed an agreement to provide the EU with 405 million doses of their mRNA vaccine.
CureVac’s close operations with European officials stood in contrast to its competitors, with Moderna relying heavily on US government cash and Pfizer providing the funding and clinical and manufacturing expertise to advance BioNTech’s vaccine. The bulk of their manufacturing will occur in Europe as well, with the company announcing plans this morning to establish a European-based network of factories that can produce 300 million doses in 2021 and 2022.
CureVac did not say on what timeline they will deliver the 405 million doses to Europe.
The new deal will add to the up to 300 million doses Pfizer and BioNTech agreed to sell to the EU and the 300 million-dose deal Sanofi and GSK signed back in September. Moderna is still in discussions with the European Commission, with officials reportedly looking to negotiate the price down to below $25 per dose.
Ursula von der Leyen“This is the fifth contract with a pharmaceutical company for our COVID-19 vaccine portfolio. And we are working on a sixth one, with Moderna,” European Commission president Ursula von der Leyen said in a statement. “We hope to finalise the contract soon.”
CureVac is still in Phase I of clinical testing. They have talked about receiving approval by the third quarter of 2021 and touted a vaccine that’s stable at refrigerator temperatures as a key advantage over other mRNA approaches.
After Moderna, Pfizer news, World Health Organization cautions long road ahead
The world now has data to suggest two vaccines are highly effective against Covid-19, but WHO officials cautioned Monday that proof a vaccine works is just one small step in a long path toward ending the pandemic.
Edward Kelly“It’s not vaccines that save people,” Edward Kelly, director of the WHO’s work on service delivery and safety, told reporters, according to The Washington Post. “It’s vaccinations that will actually save people.”
And it will take a long time to vaccinate the globe. As companies and officials have warned, doses will be in short supply for the foreseeable future; Moderna and Pfizer expect to make enough to vaccinate between 800 million and a billion people next year, but the world population numbers more than 7 billion.
Moreover, the cold chain requirements for each vaccine will limit how widely they can be distributed in less developed areas of the world. Meanwhile, wealthy countries and particularly the US have bought much of the early supply of vaccine, leaving low and middle income parts of the world waiting.
These factors, along with lingering unknowns about how long the vaccines last and the still-surging levels of virus, underscore the need to continue measures such as social distancing and testing, officials said.
“A vaccine on its own will not end the pandemic,” WHO Director-General Tedros Adhanom Ghebreyesus said.
Pfizer begins pilot program to distribute its vaccine
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 “thermal shippers” that can be stored at room temperature and keep the vaccine cold for 10 days if replenished with dry ice, which they say will lessen the burden on countries.
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 drugmakers 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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