Adienne SA

With headlines around the globe focused on various hitches in the global supply chain for Covid vaccines, President Joe Biden is taking out an insurance policy of sorts to help guarantee his promise to rapidly expand access. Earlier in the week the president announced plans for a new contract with J&J covering an added 100 million doses of their one-shot jab to guard against Covid-19, to be delivered in the second half of the year. And much of that work will be done at Merck’sDurham, NC facility, which recently announced plans to expand its workforce by 100 at the 900,000-square-foot plant. Biden has been leveraging larger supply commitments from the two leaders in the field — Pfizer, partnered with BioNTech, and Moderna. But the president wants a surplus deal to help make sure he doesn’t miss the mark. These added doses could be used to expand the campaign to children, keeping supplies flowing in order to shut down the pandemic in the US. So far, the US has ordered 800 million doses of vaccine, more than enough to cover everyone in the country. Biden has been determined to deliver on the vaccines in short order, locking up raw materials and pressing for more than enough doses to cover the target US population — even as poor countries struggle to get any deliveries. He’s promised to have enough vaccine to have every adult vaccinated by the end of May. The press event bypassed Emergent BioSolutions, which had been on the schedule, after the New York Times raised questions about Emergent’s “outsize influence over the Strategic National Stockpile, the nation’s emergency repository of drugs and medical supplies.” — John Carroll BioNTech CEO preps plans to gear up 3 billion doses next year Pfizer and BioNTech could ramp up manufacturing to produce 3 billion vaccine doses next year, the German biotech’s CEO told Bloomberg TV. BioNTech CEO Ugur Sahin said during the interview this week that the partners already have 1.3 billion dose orders in the book, and the ability to pump out 2 billion doses in 2021. In total, 300 million of those doses have been promised to the US. And governments are discussing options for hundreds of millions more doses, according to Sahin. “In principle, we could further increase manufacturing capacity,” the chief executive told Bloomberg. “It depends on demand, it depends on factors such as if an additional boost to vaccinations is required.” Demand could significantly rise in the coming months, as Pfizer tests booster options, including a third dose of the current vaccine and a new formulation that specifically targets a concerning variant that emerged in South Africa. The news comes amid a bumpy rollout for Pfizer and BioNTech. Back in January, Italy threatened to take the vaccine developers to court, alleging that vaccine deliveries were unexpectedly cut. The companies had previously warned the EU and Canada that their allocations would be reduced as the Belgium factory was being upgraded. Germany’s Hamburg also complained of smaller shipments. And Sweden said in January that it would withhold payments to Pfizer until confusion was cleared up over how many chargeable doses are in a vial. Earlier that month, the EU found that an extra sixth dose could be squeezed out of the vials due to overfilling — but not without a special syringe. At the end of the month, the companies made an official label change specifying that each vial contains six doses, as opposed to the original five. Due to the change, CEO Albert Bourla said Tuesday that Pfizer can now supply the US with 200 million vaccines by the end of May, two months earlier than previously expected. — Nicole DeFeudis J&J says it could fall short on Q2 vaccine supply for EU — report The EU could soon be facing more vaccine distribution woes, as Johnson and Johnson worries it won’t be able to meet its Q2 quota. J&J told the EU that it was “under stress” to meet its goal of 55 million doses by the end of June, an unnamed EU official told Reuters . The company cited issues with the supply of ingredients and equipment, according to the official. The single-dose vaccine has already been authorized by the FDA, and is expected to get the OK for use in the EU on March 11. J&J is on the hook for 200 million doses to the bloc this year, and deliveries are expected to start as early as April, Reuters reported. Failing to meet the Q2 goal could spell out a headache for the EU, which has already been dealing with distribution lags. Italy threatened to take legal action back in January, alleging that deliveries of the Pfizer/BioNTech vaccine were unexpectedly cut. Germany’s Hamburg also reported receiving a smaller shipment. And last week, Italy and the EU blocked a 250,000-dose shipment of AstraZeneca’s vaccine to Australia to protect its own supply. — Nicole DeFeudis Swiss company could be first in Europe to produce Russian vaccine Swiss biopharma Adienne has reportedly struck a deal to manufacture Russia’s Sputnik V vaccine in Italy, making it the first European country to do so. Adienne inked a deal with the Russian Direct Investment Fund and says it could start producing the controversial shot as early as Q3, according to Bloomberg . The company will still need to get the OK from Italian regulators before it begins production, Reuters reported . The deal comes as tensions rise between the Russian vaccine developer and the EMA, which advised EU countries to hold off on the vaccine until it can be further reviewed for safety and efficacy. Yesterday, the shot’s developers demanded an apology from Christa Wirthumer-Hoche, head of the EMA’s management board. “We demand a public apology from EMA’s Christa Wirthumer-Hoche for her negative comments on EU states directly approving Sputnik V,” a post from the official Sputnik V Twitter account read. “Her comments raise serious questions about possible political interference in the ongoing EMA review.” A Lancet study published last month suggested Sputnik V has an efficacy rate of 91.6%. But the jab has been met with much skepticism. Russia registered the vaccine back in August — and President Vladimir Putin says his daughter took it — well before Phase III studies were completed. The move spurred much backlash, including from the Association of Clinic Trials Organizations, which wrote a letter urging Russian health minister Mikhail Murashko not to give out an unproven vaccine. “It’s not a propaganda tool, I don’t know who is saying that Russian people want to have propaganda for manufacturing a vaccine in Italy, really, it’s really absurd,” Antonio Francesco Di Naro, founder and president of Adienne, told Bloomberg’s Maria Tadeo. — Nicole DeFeudis Austria pulls a batch of AstraZeneca’s vaccine after patient death Austria has pulled one batch of AstraZeneca’s Covid-19 vaccine from the shelves after a 49-year-old woman died of “severe coagulation disorders,” according to the country’s Federal Office for Safety in Health Care (BASG). Another 35-year-old woman given the shot suffered a pulmonary embolism and is recovering, the BASG said in a statement. Both incidents occurred in people given shots from the same batch of vaccines in the Lower Austria district of Zwettl. The BASG said there’s currently no evidence the cases are tied to the vaccine. But to be safe, the government yanked the whole batch and is conducting an investigation. “Based on the known clinical data, a causal relationship cannot be established, as thrombotic events, in particular, are not among the known or typical side effects of the vaccine in question,” the BASG said. “The immediately initiated international analysis of side effect reports also shows no accumulation of similar case reports so far.” Back in January, California’s state epidemiologist called for the suspension of more than 300,000 doses of Moderna’s vaccine after fewer than 10 people who received shots from the batch suffered possible allergic reactions. Moderna said at the time that it was “unaware of comparable adverse events from other vaccination centers which may have administered vaccines from the same lot,” PBS reported . The suspensions come as vaccines are in extremely short supply, with some healthcare experts calling them “liquid gold.” Last month, South Africa slammed the brakes on the rollout of AstraZeneca and Oxford University’s Covid-19 vaccine after data showed it did not protect against mild-to-moderate cases caused by the B.1.351 variant, which is now widespread in the country. The government later said it’s considering selling or exchanging the doses it’s already received. According to a poll from YouGov , one in four German and French respondents said they’d refuse to take AstraZeneca’s jab if offered.

With headlines around the globe focused on various hitches in the global supply chain for Covid vaccines, President Joe Biden is taking out an insurance policy of sorts to help guarantee his promise to rapidly expand access. The New York Times is reporting this morning that the president is set to announce a new contract with J&J covering an added 100 million doses of their one-shot jab to guard against Covid-19, to be delivered in the second half of the year. Biden has been leveraging larger supply commitments from the two leaders in the field — Pfizer, partnered with BioNTech, and Moderna. But the Times reports that with all the news about manufacturing issues and delivery problems, the president wants a surplus deal to help make sure he doesn’t miss the mark. These added doses could be used to expand the campaign to children, keeping supplies flowing in order to shut down the pandemic in the US. Biden has been determined to deliver on the vaccines in short order, locking up raw materials and pressing for more than enough doses to cover the target US population — even as poor countries struggle to get any deliveries. He’s promised to have enough vaccine to have every adult vaccinated by the end of May. Today’s press event will bypass Emergent BioSolutions, which had been on the schedule, after the Times raised questions about Emergent’s “outsize influence over the Strategic National Stockpile, the nation’s emergency repository of drugs and medical supplies.” — John Carroll Pfizer and BioNTech could ramp up manufacturing to produce 3 billion vaccine doses next year, the German biotech’s CEO told Bloomberg TV. BioNTech CEO Ugur Sahin said during the interview that the partners already have 1.3 billion dose orders in the book, and the ability to pump out 2 billion doses in 2021. In total, 300 million of those doses have been promised to the US. And governments are discussing options for hundreds of millions more doses, according to Sahin. “In principle, we could further increase manufacturing capacity,” the chief executive told Bloomberg. “It depends on demand, it depends on factors such as if an additional boost to vaccinations is required.” Demand could significantly rise in the coming months, as Pfizer tests booster options , including a third dose of the current vaccine and a new formulation that specifically targets a concerning variant that emerged in South Africa. The news comes amid a bumpy rollout for Pfizer and BioNTech. Back in January, Italy threatened to take the vaccine developers to court, alleging that vaccine deliveries were unexpectedly cut. The companies had previously warned the EU and Canada that their allocations would be reduced as the Belgium factory was being upgraded. Germany’s Hamburg also complained of smaller shipments. And Sweden said in January that it would withhold payments to Pfizer until confusion was cleared up over how many chargeable doses are in a vial. Earlier that month, the EU found that an extra sixth dose could be squeezed out of the vials due to overfilling — but not without a special syringe. At the end of the month, the companies made an official label change specifying that each vial contains six doses, as opposed to the original five. Due to the change, CEO Albert Bourla said Tuesday that Pfizer can now supply the US with 200 million vaccines by the end of May, two months earlier than previously expected. — Nicole DeFeudis Swiss biopharma Adienne has reportedly struck a deal to manufacture Russia’s Sputnik V vaccine in Italy, making it the first European country to do so. Adienne inked a deal with the Russian Direct Investment Fund and says it could start producing the controversial shot as early as Q3, according to Bloomberg . The company will still need to get the OK from Italian regulators before it begins production, Reuters reported . The deal comes as tensions rise between the Russian vaccine developer and the EMA, which advised EU countries to hold off on the vaccine until it can be further reviewed for safety and efficacy. Yesterday, the shot’s developers demanded an apology from Christa Wirthumer-Hoche, head of the EMA’s management board. “We demand a public apology from EMA’s Christa Wirthumer-Hoche for her negative comments on EU states directly approving Sputnik V,” a post from the official Sputnik V Twitter account read. “Her comments raise serious questions about possible political interference in the ongoing EMA review.” A Lancet study published last month suggested Sputnik V has an efficacy rate of 91.6%. But the jab has been met with much skepticism. Russia registered the vaccine back in August — and President Vladimir Putin says his daughter took it — well before Phase III studies were completed. The move spurred much backlash, including from the Association of Clinic Trials Organizations, which wrote a letter urging Russian health minister Mikhail Murashko not to give out an unproven vaccine. “It’s not a propaganda tool, I don’t know who is saying that Russian people want to have propaganda for manufacturing a vaccine in Italy, really, it’s really absurd,” Antonio Francesco Di Naro, founder and president of Adienne, told Bloomberg’s Maria Tadeo. — Nicole DeFeudis For a look at all Endpoints News coronavirus stories, check out our special news channel .