“I think the US is probably one of the first countries to get population protection,” Moderna Chief Executive Stéphane Bancel said this week in a key discussion at the JP Morgan Healthcare Conference, the biopharmaceutical investor conference. Yearly.
But the amount on paper is different from vials in the freezer or vaccinations in people’s arms, as demonstrated over the past several months. Distribution challenges attract the most attention as unused volumes increase. But the risk of raw material shortages, production delays and other unexpected manufacturing problems poses potential bottlenecks as companies work to reach mass production.
Pfizer-BioNTech and Moderna raised their forecasts for global production over the past two weeks, citing increased experience and production efficiencies, but companies with vaccine candidates are still in clinical studies. The report is a production challenge, reflecting Pfizer̵7;s declining timeline last fall, when the company lowered its production forecast from 100 million doses by the end of 2020 to 50 million.
Johnson & Johnson, which has one vaccine at the final stage of the test, agreed to a contract with the U.S. government to supply 12 million doses by the end of February. But this week, Moncef Slaoui Scientific adviser for Operation Warp Speed, the Trump administration’s initiative to speed up vaccine development, said the company was working as it would have. “Millions of doses available in the second half of February” The initiation of clinical trials for Novavax vaccine candidates was delayed by several months, in part due to production delays.
Johnson & Johnson spokesman Jake Sargent said production of the company’s vaccine had begun and the drugmaker was confident it could deliver the promised amount of the vaccine for 2021, but did not say it would. When is the vaccine delivered?
“We are still in discussions with regulators, including approval and validation of our production processes,” Sargent said.
Novavax trials begin in October, begin in late December. Chief Executive Stanley C. Erck said at JP Morgan that the company has now established a “robust” manufacturing process.
“It’s a challenge to go from small to large, and you get to learn things along the way,” Erck said.
In addition to 400 million doses from Moderna and Pfizer-BioNTech. The United States has already agreed to buy 600 million doses of the vaccine in its development, which, if it shows it is effective and companies can meet production goals, it will accelerate the vaccination campaign. Having multiple vaccines developed using different technologies will prevent supply chain shortages or delays caused by the diversity of making complex biological products.
Norman W. Baylor, chair of biology consultancy and former expert on vaccine regulations for the Food and Drug Administration, stressed that industrial production of vaccines is not easy, although companies say they can get it. Convinced they will be able to overcome their already ambitious goals, but Baylor has also called for more transparency about weekly production volumes and emissions.
Suddenly you received a phone call and said, ‘Norman, we are in trouble and we won’t be able to release a vaccine for a month,’ ”Baylor said, recalling past shortages of vaccines.
Baylor said vaccine companies are expanding to meet unprecedented demand, often with new technologies that are not used in large quantities, with complex planning. This is in contrast to the pediatric vaccine, which is a familiar product to drug manufacturers. In the United States, about 4 million doses of different types of vaccines are available for children annually, drug companies are now racing to vaccinate billions of doses of coronavirus and get it out of the gate.
“You may have some problems, especially with biological systems, where they’re not working as they should,” Baylor said. “It’s not like taking aspirin.”
Pfizer-Biotech executives recently announced they will produce 2 billion doses worldwide this year, a 50 percent increase from previous estimates. Pfizer realized after beginning vaccine delivery that the five vials contained a sixth dose, which regulators said could be used. The remainder of the increases reflect more efficient production and an increase in raw materials, said Pfizer chief executive Albert Bourla.
“We say what we mean and we mean what we say. So when we say something, we feel confident that we can do that, ”Bourla said. From specific raw materials according to the desired size “
Some vaccination locations, including those offered by Premier, a healthcare company representing more than 4,100 health systems, have expressed concerns that they do not have enough syringes and syringes to deliver the drug. Sixth in a Pfizer bottle
The Department of Health and Human Services said it was working with Pfizer and its distributors to add the syringe and needle device.
Pfizer spokeswoman Amy Rose admitted that it was uncertain the company could deliver 2 billion doses of the drug, but the company was more confident it could meet that goal.
“We believe we can achieve this commitment through our vaccine expertise and extensive production network. And we remain confident that we will reduce inherent risks as we source additional raw material suppliers, increase the redundancy in our capabilities and increase our capacity with contract manufacturers. “Rose said in an email.
Moderna edited last week. Projected to be able to produce worldwide this year from 500 million to 600 million, Moderna has broad goals for production this year, suggesting it will try to do 1 billion doses, but will strive to produce it. Half of which is the period that shows how much uncertainty there is
In a presentation by J.P. Morgan Bancel, CEO of Moderna, two factors affect the projection. The first is the return on production – the amount the company receives from each batch, sometimes higher than expected, and at other times lower than the other factor is the availability of raw materials, even if the company works to keep it safe. And distributing suppliers, but Bancel said he could not know for sure that on calendar dates there would be necessary raw materials on hand, even if the company worked to create a reserve supply.
“We work 24 hours every day. So if on that day for one shift… If that day there is a lack of raw materials, we can’t start producing the product and that capacity will be lost forever because we can’t make it, ”Bancel said.
The tug of war between distribution and procurement could happen in the coming months. But in the United States, Operation Warp Speed’s leaders are anticipating the possibility of too many vaccines. And the dosing challenge may become more difficult as more people get the vaccine.
Scott Gottlieb, a former FDA committee member in the Trump administration, told CNBC’s “Squawk Box” he expects demand to rise.
“We live in this belief that the demand here is endless and it isn’t,” Gottlieb said. “I think by the end of February we will find that we have to widen the qualifications for people to get vaccinated. We will not be in this allocated situation. “