Pfizer and partner BioNTech will only be able to ship half as many doses of its coronavirus vaccine as it promised by the end of the year, cutting its planned global rollout from 100 million to 50 million doses, sources told the Wall Street Journal.
The companies had to walk back its plan due to slowdowns in its supply chain.
‘Scaling up the raw material supply chain took longer than expected,’ a company spokeswoman told the WSJ.
‘And it’s important to highlight that the outcome of the clinical trial was somewhat later than the initial projection.’
Pfizer’s vaccine was given temporary approval by UK regulators on Wednesday, and is expected to get emergency use authorization from the U.S. Food and Drug Administration following the agency’s December 10 meeting.
The UK ordered 40 million doses of Pfizer’s vaccine, with the expectation it could vaccinate 10 million people by year-end. That number will now likely be closer to five million.
Operation Warp Speed, the U.S. vaccine initiative, expected to have 40 million doses – enough to inoculate 20 million people with each of the two-dose shots – in total from both Pfizer and Moderna by the end of the year.
Now, the U.S. will likely get just 10 million doses of Pfizer’s vaccine this month, covering just five million Americans. The first 6.4 million doses were supposed to go out shortly following the expected authorization of Pfizer’s shot in mid-december.
After the disappointing revelation about Pfizer’s rollout, Moderna assured Americans it is still on track to deliver 20 million doses of its vaccine to Americans by year-end, pending emergency FDA approval.
Shares for Pfizer fell 1.74 percent after its reduced rollout plan was revealed.
It’s a second sobering blow to the American coronavirus struggle in 24 hours as the U.S recorded its highest single-day death toll of 2,804 on Tuesday.
Pfizer will only be able to ship half as many doses of its coronavirus vaccine as it promised by the end of the year. Pictured: Refrigerated trucks equipped to deliver the vaccines leave a Pfizer plant in Belgium (file)
Shares for Pfizer fell 1.74 percent after it was revealed the firm would not meet its 2020 coronavirus distribution goal
‘We were late,’ a source involved in the development of Pfizer’s vaccine told the WSJ.
‘Some early batches of the raw materials failed to meet the standards. We fixed it, but ran out of time to meet this year’s projected shipments.’
Pfizer began setting up its supply chain for the new vaccines in March, but pushed to ramp up production last month as it neared the end of its late-stage clinical trials and began to see promising results.
Even then, the supply chain started to falter.
Pfizer spokeswoman Amy Rose admitted that the firm wasn’t hitting its production goals because raw materials were taking longer than anticipated, according to a New York Times article first published in November and updated on Wednesday.
Both Pfizer and Moderna designed their coronavirus vaccine using a new technology.
If it gets emergency use authorization from the FDA next week, Pfizer’s COVID-19 shot will be the first mRNA shot on the market.
These shots introduce mRNA – a type of genetic material that transports instructions for making protein components of cells – from the virus to our cells. These instructions teach our body to make one harmless piece of the virus, but not the virus itself.
That’s enough, however to teach our body to recognize the real virus, react, and do a better job of fighting it off.
United chartered flights are transporting Pfizer’s COVID-19 vaccine in the US, where the firm will likely only deliver 10 million doses by year-end (file)
Most vaccines use a weakened version of a different virus to deliver a piece of the target virus to our bodies to teach our immune systems the same skills.
There are another of mRNA vaccines in trials, but with none approved, no one has ever mass-produced them before.
And now COVID-19 vaccines are needed more urgently, on a more massive scale, than perhaps any vaccine before.
Pfizer had to buy new equipment to make its coronavirus vaccine, and the urgency of the pandemic meant the firm had to start buying up this equipment before it normally would have.
‘For this one, everything happened simultaneously,’ the vaccine development source told the WSJ.
‘We started setting up the supply chain in March, while the vaccine was still being developed. That’s totally unprecedented.’
Production setup fell behind while the clinical trial dragged on beyond what Pfizer planned.
The company expanded its phase 3 trial from 30,000 to 44,000 participants in September.
More trial participants meant more doses of the vaccine, and less focus of resources on the supply chain.
After the trial expansion, Pfizer turned its attention back to production and supply chain reinforcement, Rose, the company spokesperson, told the New York Times, but it was playing catch up.
Even before revealing that it would not meet its 100 million dose goal for 2020, Pfizer’s vaccine has been viewed as more delicate and unstable than most.
Namely, it has to be stored at extraordinarily cold temperatures: -94° F.
That layer sits on top of the trays the vaccines are stored in. There are five vials to one tray
This is how the vaccines will be sent out in their millions by Pfizer
A laywer of dry ice is also inside the box to ensure that it is kept cold enough
The company has devised shipping and storage containers that use dry ice to achieve the ultra-cold environment needed to keep the jab stable.
But that box, New York Governor Andrew Cuomo said on Thursday, can only be opened twice, for 30-90 seconds each time, presumably to prevent the contents of each vaccine vial from thawing.
Pfizer’s bespoke vaccine packages come equipped with geotrackers and thermometers to ensure they’re not lost or destroyed by thawing.
The frozen vial then must be thawed, which takes about half an hour, before it gets diluted to the appropriate concentration – a process which requires the vaccine to stand for two hours.
It’s then viable for six hours – a short window for the vaccine to be administered.
‘The vaccine process is a complicated process and the distribution is going to take a lot of work and a lot of effort,’ Cuomo said during a Thursday press conference.
Pending the verdict of the FDA next week, Pfizer was planning to ship 6.4 million doses of the shot – enough to vaccinate 3.2 million people with two doses – this month.
It is unclear yet whether this first wave of jabs will be reduced in light of the supply chain issue.
HOW DO THE MODERNA AND PFIZER/BIONTECH VACCINES COMPARE?
Moderna and Pfizer/BioNTech have both released interim results of the final stage clinical trials of their vaccines, with both suggesting they are extremely effective.
Here’s how they compare:
PFIZER (US) & BIONTECH (DE)
mRNA vaccine – Genetic material from coronavirus is injected to trick immune system into making ‘spike’ proteins and learning how to attack them.
mRNA vaccine – both Moderna’s and Pfizer and BioNTech’s vaccines work in the same way.
94.1% effective (90 positive in placebo group, 5 positive in vaccine group)
90% effective (estimated 86 positive in placebo group, 9 positive in vaccine group)
US has secured 100million doses for $1.525billion (£1.16bn), suggesting it will cost $15.25 (£11.57) per dose; $30.50 (£23.14) per person.
US will pay $1.95bn (£1.48bn) for the first 100m doses, suggesting a cost of $19.50 (£14.80) per dose; $39 (£29.61) per person.
Moderna will produce 20m doses this year, expected to stay in the US.
First vaccinations expected in December.
What side effects does it cause?
Moderna said the vaccine is ‘generally safe and well tolerated’. Most side effects were mild or moderate but included pain, fatigue and headache, which were ‘generally’ short-lived.
Pfizer and BioNTech did not produce a breakdown of side effects but said the Data Monitoring Committee ‘has not reported any serious safety concerns’.