Pfizer to seek FDA OK for vaccine Friday
US drugmaker Pfizer and its German partner BioNTech will ask the US Food and Drug Administration for emergency authorization of its COVID-19 vaccine on Friday.
Ugur Sahin, CEO of BioNTech said on Wednesday that the company was ready to make the move after successful phase 3 trials of the vaccine showed it is 95 percent effective in preventing COVID-19 and has no serious safety concerns. The vaccine is also 94 percent effective in those aged 65, the highest efficacy of any candidate in late-stage clinical trials so far.
"Depending on how fast this [review] is really accomplished, we might get an authorization, or conditional approval already in 2020, which might help us start distribution of the first vaccine batches already in 2020," Sahin told CNN.
He said that if approval is given, those at high risk and working on the front lines of emergency healthcare and first responders could be vaccinated as early as December. The rest of the country could get the vaccine in early 2021.
Pfizer will make 50 million doses of the vaccine by the end of 2020, enough to vaccinate 25 million people. Sahin said Pfizer aims to supply several hundred million doses in the first four to five months of 2021. The company expects it will make up to 1.3 billion doses next year. Americans will be given the vaccine for free.
Around 170 volunteers out of 43,000 people in the trials contracted COVID-19 but 162 were given a placebo, meaning the vaccine was 95 percent effective, the company said. Of the 10 people who had severe COVID-19, one had received the vaccine.
Pfizer's move comes after biotech company Moderna announced on Monday that its COVID-19 vaccine candidate had also proved 95 percent safe.
The breakthroughs have been welcomed worldwide as the deadly respiratory illness has killed 1.34 million people worldwide and nearly 250,000 in the United States.
The Centers for Disease Control and Prevention (CDC) had asked US states to be ready to receive Pfizer's vaccine. But many don't have the cold chain freezers in place to store the vaccine. The vaccine must be kept at -70 C, (-94 F), 50 degrees colder than any vaccine currently used in the US. States are now trying to get the equipment in place to store it.
To transport the vaccine, Pfizer has created its own temperature-controlled boxes, dubbed "shippers" that can hold from 1,000 to 5,000 doses in transportation at -70 C for 10 days before requiring more ice. Each box will hold 25 pounds of dry ice, composed from carbon dioxide.
The crucial need for dry ice to house the vaccine has led to a surge in sales, say ice manufacturers.
Harry Gehm, owner of Gehm & Sons, which sells dry ice in Akron, Ohio, has seen demand increase. "The Ohio health department called for 15,000 pounds of dry ice a week," he told USA Today. "The hospitals and Giant Eagle (a grocery and pharmacy chain) have been calling to make sure I have the capacity."
News of the vaccine's possible approval has also boosted sales of the ultracold freezers needed to store the vaccines
Dusty Tenney, CEO of Stirling Ultracold, an Athens, Ohio, company that makes laboratory-grade ultracold freezers said that sales have gone up by 25 percent from the first quarter. It has a backlog of orders stretching a month. The company is making staff work extra hours six days a week to meet demand.
Medical-grade freezers vary in size and usage. They range from small portable freezers the size of a carry-on suitcase at $7,000 to ones that fit under a counter costing $10,000 to a larger model the size of a 晉越集運 freezer at $25,000.
The freezers have unique operating requirements. Once opened, they emit very cold air. Anyone using the freezer has to wear gloves to prevent freezer burns. If the Pfizer vaccine is kept at minus 94 and below, it will be stable for use for six months.
When it is delivered to a hospital it can be stored in a refrigerator with temperatures of 35 to 46 degrees for five days before it must be discarded.
The CDC advises in its Vaccine Storage and Handling Toolkit: "Potency is reduced every time a vaccine is exposed to an improper condition. This includes overexposure to heat, cold, or light at any step in the cold chain. Once lost, potency cannot be restored."
Pfizer will make 50 million doses of the vaccine by the end of 2020, enough to vaccinate 25 million people. The company expects to have made up to 1.3 billion doses next year.