HHS Secretary Alex Azar says US will have 40 million doses of COVID-19 vaccines by next month after Pfizer says it will seek FDA approval for its 95% effective shot this week... days after Moderna's breakthrough
The United States will have 40 million doses of COVID-19 vaccines created by Pfizer and Moderna by the end of the year, according to Health and Human Services Secretary Alex Azar.
Azar also said vaccines from both drugmakers could be ready for US authorization and distribution within weeks - yet another sign that initial vaccinations could begin as soon as next month.
'We now have two safe and highly effective vaccines that could be authorized by the FDA and ready to distribute within weeks,' Azar said during his briefing on the government's Operation Warp Speed program for COVID-19 vaccines on Wednesday.
Around 40 million doses of the two vaccines, both of which require two shots about four weeks apart, will be available by the end of the year and the companies will be able to produce more than 40 million doses a month for Americans every month thereafter, officials said on the call.
States and territories are prepared to begin distributing the vaccines within 24 hours of receiving regulatory authorization, the officials added.
The remarks came just hours after Pfizer revealed that it would apply for emergency use authorization from the FDA this week after final results from its late-stage trial showed the vaccine was safe and 95 percent effective.
The drugmaker, which developed its vaccine with German partner BioNTech SE, made the newest claim about its shot just one week after initial results from the trial showed it was more than 90 percent effective.
Rival US company Moderna on Monday released preliminary data showing its own vaccine was 94.5 percent effective.
Operation Warp Speed officials said the Moderna vaccine is likely to be authorized within seven to 10 days of Pfizer receiving emergency use authorization. Full formal approval is likely to follow in about three months.
Pfizer said on Wednesday it will apply for emergency use authorization from the FDA within days after final results from its late-stage trial of its COVID-19 vaccine showed it was 95 percent effective
In addition, officials said two more vaccines will likely have early data ready within the coming weeks.
COVID-19 vaccine program head Moncef Slaoui said there will not be any constraints on who gets what vaccine. He said government officials and private companies are ready to distribute the vaccines to all parts of the country.
Officials said on Wednesday that complex cold storage requirements will not be an impediment to all Americans being able to access the vaccines.
The government faces the huge task of transporting and storing Pfizer's vaccine once it is distributed. Pfizer's vaccine requires ultra cold temperatures of -94F, which may require expensive specialist freezers and huge supplies of dry ice.
Officials say Moderna's vaccine will be easier to distribute, particularly to rural areas, because it can be stored for one month at standard refrigerator temperatures.
The better-than-expected data from the two vaccines, both developed with new technology known as messenger RNA (mRNA), have raised hopes for an end to a resurgent pandemic that has killed more than 248,000 Americans and wreaked havoc upon economies and daily life.
Officials have said they hope to have about 20 million vaccine doses each from Moderna and Pfizer available for distribution in late December.
The first shots will be offered to vulnerable groups like medical and nursing home workers, and people with serious health conditions.
An expert panel advising the CDC is meeting next week to determine the order of priority for vaccines distribution.
It will be months, however, before large-scale roll-outs begin.
Following the completion of its trial, Pfizer said only eight people out more than 20,000 who got the vaccine caught coronavirus in the study, compared to 162 who were given a fake jab. A total of 10 people got severe COVID-19, one of whom had been given the real vaccine.
Pfizer shares initially rose 2 percent off the back of the announcement, while BioNTech's US-listed shares jumped 4 percent.
The company said that efficacy of its vaccine was consistent across age and ethnicity demographics and that there were no major side effects, which is a sign that the immunization could be employed broadly around the world.
Efficacy in adults over 65 years, who are at particular risk from the virus, was over 94 percent.
Pfizer initially had estimated its vaccine was was more than 90 percent effective after 94 infections had been counted.
Pfizer said there had been 170 cases of the disease in its trial of more 43,000 volunteers, of which 162 were observed in the placebo arm and eight were in the vaccine group.
Ten people developed severe COVID-19, one of whom received the vaccine.
It also said the vaccine was well-tolerated and that side effects were mostly mild to moderate and cleared up quickly.
The only severe adverse event that affected more than 2 percent of those vaccinated was fatigue, which affected 3.7 percent of recipients after the second dose.
Older adults tended to report fewer and milder solicited adverse events following vaccination.
The company has not yet released detailed data on its study and results have not been analyzed by independent experts.
It is not yet clear how long a COVID-19 vaccine will last in a person, and whether it will need to be administered annually.
The trial will continue to collect safety and efficacy data on volunteers for two more years.
The results come as the virus is running rampant in the US and placing an enormous strain on healthcare systems with record numbers of new cases and hospitalizations.
'With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world,' Pfizer CEO Albert Bourla said in a statement.
Pfizer and BioNTech also said they plan to submit the data to other regulatory agencies around the world as well as the US. They also plan to submit data from the study to a peer-reviewed scientific journal.
Pfizer reiterated it expects to make as many as 50 million vaccine doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.
Of the dozens of drugmakers and research groups racing to develop vaccines against COVID-19, the next data release will likely be from AstraZeneca Plc with the University of Oxford this month or in December.
Johnson & Johnson says it is on track to deliver data this year.
Meanwhile, former FDA commissioner Dr Mark McClellan said that the current spike in COVID-19 cases in the US would likely be 'last big surge' before a vaccine is readily available.
'The months ahead are going to look better than the weeks ahead,' he said. 'Things are going to start gradually getting better,' he said. 'Won't be past this for still months to come. But it will start getting better by early 2021.'
Pfizer, which developed the vaccine with German partner BioNTech SE, said it now has the two months of safety data it needs to apply for emergency use
Pfizer shares rose 2 percent off the back of the announcement, while BioNTech's US-listed hares jumped 4 percent
The vaccine developed by Pfizer, which is on track to be the first authorized for use in the US, must be stored at -94F.
Other vaccines currently being developed do not need to be stored as such a low temperature. Moderna's vaccine can be stored at -4 degrees Fahrenheit, which is the temperature of a normal freezer.
Other vaccines, including ones from Johnson & Johnson and Novavax Inc, can be stored at 35F, which is the temperature of a regular refrigerator. In comparison, the regular flu vaccine can be kept in a normal refrigerator.
Pfizer's vaccine poses the biggest logistical issues given that even the most sophisticated hospitals in the country don't have enough ultra-cold freezers to be able to store the doses.
The drugmaker said the company was working closely with the federal government and state officials on how to ship the vaccine from its distribution centers in Michigan and Wisconsin.
Pfizer, in a bid to overcome the freezer issue, has created thermal shipping containers so the vaccines are stored at the correct temperatures.
The vaccines can remain in the thermal container it is shipping in for 10 days.
Each thermal shipping container will be filled with dry ice and 975 vials of the vaccine, which each contain five doses, for a total of 4,875 doses. Pfizer says providers can replenish the dry ice up to three times for an additional 15 days, if needed.
Once the packages containing the vaccines are opened, the doses have to be stored in normal refrigeration temperatures of slightly above freezing.
They have to be used within five days of being refrigerated and the doses can't be refrozen if unused.
Pfizer says the packages, however, can only be opened twice a day.
If the doses are being stored in an ultra-low temperature freezer at a hospital, for example, the vaccine can last up to six months.
The CDC, in its guidance to health departments, says if a dose is removed directly from an ultra-cold temperature it needs to be at room temperature for 30 minutes in order to thaw before being diluted.
Once the vaccine is thawed, it needs to be diluted within two hours. The diluted vaccine must be used within six hours. If the dose is unable to be diluted within the two hour time frame, it needs to be stored in the refrigerator.
'Most vaccines need cold chain storage and we have already initiated development of innovative cold-chain solutions and distribution logistics to facilitate vaccine supply,' a Pfizer spokesperson said. 'We have also developed packaging and storage innovations to be fit for purpose for the range of locations where we believe vaccinations will take place.'
The responsibility to obtain dry ice will fall on state health departments and providers.
A spokesperson for the Health Department said only one vaccine candidate - meaning Pfizer - required such extreme ultra-cold storage and transport.
'(Operation Warp Speed) has been diligently working with vaccine manufacturers to ensure administration sites have the capabilities to receive and maintain a vaccine with cold-storage requirements for up to 10 days,' the spokesperson said.
'Administration sites can repack opened shipping containers with dry ice multiple times for an additional 15 days. If a shipment of vaccine doses is at risk of expiring, OWS will guide the movement of those doses to sites with larger demand.'
Pfizer has already said it will distribute its own vaccine from its facilities in Kalamazoo, Michigan and Pleasant Prairie, Wisconsin because of the freezer requirements. The drugmaker has already created a staging ground at its Michigan facility complete with 350 large freezers to hold the vaccines once they're created and ready to ship.
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