
Covid-19 roundup: Moderna inks fill-finish pact with Samsung Biologics; Soriot discusses vaccine woes, says shot 'has a future' — report
As Moderna has ramped up its manufacturing capabilities and looks to distribute its vaccine doses to countries in dire need, the company has inked a deal with South Korean CDMO Samsung Biologics for fill-finish duties.
Samsung’s production line in Incheon will support the production of 100s of millions of doses, good for distribution at the start of Q3. Korea has secured 40 million doses of the vaccine.
Moderna announced Friday that its vaccine was approved by the Japanese and South Korean governments. Distribution will happen in Japan immediately, with the help of Takeda, as a part of a 3-way agreement. Novavax will help manufacture the jab in Japan.
Samsung’s stock rose as much as 5.2% after the contract was announced.
The move comes as vaccine makers make the push to get doses to Asia. Last week, Germany’s BioNTech, which collaborated with Pfizer on its vaccine, announced that the company will set roots down with an Asia regional headquarters in Singapore as the demand for mRNA vaccines has skyrocketed.
In late April, Moderna announced its plans to turbocharge its supply chain and up its global commitment to 3 billion doses in 2022, doubling capacity at contract sites in Switzerland and Spain run by Lonza and Rovi, respectively, and increasing drug substance manufacturing by 50% at its US facilities. The expansions will also allow Moderna to now produce between 800 million and 1 billion doses in 2021, the company said.
That move was inspired, according to CEO Stéphane Bancel in a previous interview with Endpoints News, to provide doses and boosters to countries in need.
“We said ‘what can we do for the world?’ and we basically went back to our board and said ‘we need to do massive investment,’” Bancel told Endpoints. “We need to aim to increase our capacity for next year so that we can make sure we can vaccinate and boost everybody.” — Josh Sullivan
Pascal Soriot says AstraZeneca vaccine ‘has a future’ in new interview
AstraZeneca has had its share of speed bumps regarding development for its Covid-19 vaccine, and CEO Pascal Soriot dished on some of the setbacks and opined on the shot’s future in a new interview with the Financial Times.
Among the highlights? Soriot believes the company’s vaccine “has a future” given the sheer number of countries around the world that are signing up for deliveries. He also discussed the disparity between the vaccine’s rollout in the UK compared to the rest of Europe, and referred to the much-maligned US Phase III data release as an “own goal.”
The comments were his first since the European Commission said it would pursue legal action against the company over a shortfall in vaccine deliveries.
“I’m a European so I love Europe, don’t get me wrong,” he told FT. “But at the end of the day Europe is part of the world, it’s not the whole world. And there are many countries around the world who actually want this vaccine, so this vaccine has a future.”
One of the reasons behind many of the EU countries’ frustrations had been the UK’s priority access to the vaccine. Soriot reiterated that the country had been granted such access as part of the agreement it signed with Oxford University before the Big Pharma partnered to help manufacture and distribute the shot.
He praised the UK’s decision to appoint someone from the industry to run the country’s vaccine rollout in Kate Bingham, a venture capitalist. But he stopped short of criticizing the EU directly over whether it should have taken a similar tactic.
Among AstraZeneca’s high-profile stumbles came back in March, when the company reported its Phase III interim results. After the company painted a good picture in a press release, the NIH published an extraordinary statement saying the company may have included outdated data in its results.
NIAID chief Anthony Fauci had called the move an “unforced error” at the time, and Soriot appeared to agree with his “own goal” comment. According to Soriot’s accounting of the ordeal, researchers were rushing to get out the data and simulated what the final results would look like while forgetting to inform the DSMB.
“It is not typically necessary but out of politeness and out of good practice, they should have told them,” Soriot said. “People have worked so hard, they were tired, they were rushing.” — Max Gelman
Novavax to explore dual flu-Covid-19 vaccine with SK biosciences
Novavax, SK Bioscience and the Korean ministry of health have signed an agreement to explore the development of Novavax’s Covid-19 vaccine.
The deal was announced in a ceremony hosted by South Korean President Moon Jae-in. It expands on a deal that was intended to provide broad access to NVX-CoV2373 globally. As a part of the agreement, SK and Novavax will explore vaccines that combat Covid-19 variants and the possibility of a vaccine that would fight both Covid-19 and the flu.
NVX-CoV2373 is in 2 pivotal Phase III trials: 1 in the UK that demonstrated 96.4% efficacy against the original virus strain and 86.3% efficacy against the variants, and a US/Mexico PREVENT-19 trial.
SK Bioscience began the submission process for the vaccine to the South Korean government in April.
First patients in Pfizer 20vPnC trial have been jabbed
The first of 600 adults that will receive a dose of the Pfizer-BioNTech 20-valent pneumococcal conjugate vaccine have received their jab, Pfizer announced Monday.
The trial is exploring the co-administration of 20vPnC with a booster dose of the Pfizer-BioNTech vaccine that’s been approved by the FDA. It will describe safety when the vaccines are co-administered, and follow up 6 months after vaccination, the company said.
The patients will be a part of 1 of 3 groups. The first group will receive the 20vPnC vaccine plus the Pfizer-BioNTech booster. The second will receive 20vPnC and a placebo, and the third will receive the Pfizer-BioNTech jab and a booster.
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