Pfizer and BioNTech have asked the US health regulator to relax requirements for their Covid-19 vaccine, so that instead of being stored at ultra-low temperatures, it could be kept in pharmacy freezers, the companies said on Friday.
Approval by the Food and Drug Administration could send a strong signal to other regulators around the world that may ease distribution of the shot in poor countries.
The companies have submitted new temperature data to the agency to support an update to the current label that would allow vials to be stored at minus 25 to minus 15°C (minus 13°F to 5°F) for a total of two weeks.
The current label requires the vaccine to be stored at temperatures between minus 80ºC and minus 60ºC (minus 112ºF to minus 76ºF), meaning it has to be shipped in specially designed containers.
The shot's cold-storage requirements set off a scramble among US states at the beginning of the vaccination programme for dry ice, which can be used temporarily when there are no specialised freezers available.
Pfizer-BioNTech's vaccine, along with Moderna's two-dose shot, has already won US emergency-use authorisation and is being widely distributed as part of the country's mass vaccination efforts.
The update from the drugmakers comes as two studies from Israel found that the vaccine greatly reduced virus transmission, and the shot was backed by two of the South African government's top advisers.
The new data will also be submitted to global regulatory agencies within the next few weeks, the two companies said.
A BioNTech spokeswoman declined to provide more details on the timing and which agencies would be contacted.
"The data submitted may facilitate the handling of our vaccine in pharmacies and provide vaccination centres an even greater flexibility," BioNTech chief executive Ugur Sahin said.
Deutsche Post, which has shipped Covid-19 vaccines to several European countries, Israel, Bahrain, Mexico and Singapore, among others, said minus 25 degrees would provide some relief but transportation would still not be easy.
A spokeswoman said air freight would likely no longer require dry ice on board, increasing storage capacity per plane.
BioNTech has said it imposed long-term storage and transportation requirements of minus 70 degrees out of caution because it had started stability and durability tests on its vaccine relatively late.
Even though it launched its Covid-19 vaccine development programme as early as January 2020, working on four compounds in parallel, it did not decide until July which of the four to proceed with, and only then started stability tests.
If approved, the less onerous storage requirements would provide significant logistical relief for the distribution of the vaccine worldwide, particularly in poor countries.
The World Health Organisation's Covax global vaccine-sharing programme has so far limited distribution of Pfizer-BioNTech vaccines to a few countries, partly out of concern over a lack of infrastructure in developing nations.
The WHO said it was hopeful that eased requirements could broaden its reach.
"We are aware of reports of this and look forward to seeing the data. If proven correct, this could make roll-out of the vaccine easier in all countries, and particularly in low-income ones," it said.
Moderna's product, which like Pfizer's is based on so-called messenger RNA molecules, is already cleared for storage at minus 25 to minus 15ºC
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Israel Palestine on Swedish TV 1958-1989
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Rating: 5/5
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THREE POSSIBLE REPLACEMENTS
Khalfan Mubarak
The Al Jazira playmaker has for some time been tipped for stardom within UAE football, with Quique Sanchez Flores, his former manager at Al Ahli, once labelling him a “genius”. He was only 17. Now 23, Mubarak has developed into a crafty supplier of chances, evidenced by his seven assists in six league matches this season. Still to display his class at international level, though.
Rayan Yaslam
The Al Ain attacking midfielder has become a regular starter for his club in the past 15 months. Yaslam, 23, is a tidy and intelligent player, technically proficient with an eye for opening up defences. Developed while alongside Abdulrahman in the Al Ain first-team and has progressed well since manager Zoran Mamic’s arrival. However, made his UAE debut only last December.
Ismail Matar
The Al Wahda forward is revered by teammates and a key contributor to the squad. At 35, his best days are behind him, but Matar is incredibly experienced and an example to his colleagues. His ability to cope with tournament football is a concern, though, despite Matar beginning the season well. Not a like-for-like replacement, although the system could be adjusted to suit.
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Most sought after workplace benefits in the UAE
- Flexible work arrangements
- Pension support
- Mental well-being assistance
- Insurance coverage for optical, dental, alternative medicine, cancer screening
- Financial well-being incentives
UAE currency: the story behind the money in your pockets
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Quick pearls of wisdom
Focus on gratitude: And do so deeply, he says. “Think of one to three things a day that you’re grateful for. It needs to be specific, too, don’t just say ‘air.’ Really think about it. If you’re grateful for, say, what your parents have done for you, that will motivate you to do more for the world.”
Know how to fight: Shetty married his wife, Radhi, three years ago (he met her in a meditation class before he went off and became a monk). He says they’ve had to learn to respect each other’s “fighting styles” – he’s a talk it-out-immediately person, while she needs space to think. “When you’re having an argument, remember, it’s not you against each other. It’s both of you against the problem. When you win, they lose. If you’re on a team you have to win together.”
How to join and use Abu Dhabi’s public libraries
• There are six libraries in Abu Dhabi emirate run by the Department of Culture and Tourism, including one in Al Ain and Al Dhafra.
• Libraries are free to visit and visitors can consult books, use online resources and study there. Most are open from 8am to 8pm on weekdays, closed on Fridays and have variable hours on Saturdays, except for Qasr Al Watan which is open from 10am to 8pm every day.
• In order to borrow books, visitors must join the service by providing a passport photograph, Emirates ID and a refundable deposit of Dh400. Members can borrow five books for three weeks, all of which are renewable up to two times online.
• If users do not wish to pay the fee, they can still use the library’s electronic resources for free by simply registering on the website. Once registered, a username and password is provided, allowing remote access.
• For more information visit the library network's website.
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match info
Maratha Arabians 138-2
C Lynn 91*, A Lyth 20, B Laughlin 1-15
Team Abu Dhabi 114-3
L Wright 40*, L Malinga 0-13, M McClenaghan 1-17
Maratha Arabians won by 24 runs
