Pfizer’s vaccine no longer needs ultra-cold storage – it can stay between -25 and -15 degrees

Pfizer Yes BioNTech announced this Friday the presentation of new data to the United States Food and Drug Administration (FDA, for its acronym in English) which demonstrate the stability of your coronavirus vaccine when stored for two weeks at -25 ° C to -15 ° C, most common in pharmaceutical freezers and refrigerators.

This would serve as an alternative or supplement to storage in a very low temperature freezer. Currently, the vaccine data sheet states that it should be stored in a freezer ultra-cold at temperatures between -80 ° C and -60 ° C for a period of up to 6 months.

Vaccines are shipped in an insulated container specially designed by Pfizer It can be used as temporary storage for a total of up to 30 days by refilling with dry ice every five days. This generates logistical problems for its transport to parts of the world with worse preparation for these circumstances, such as Africa.

Before mixing with saline diluent, the vaccine can also be refrigerated for up to five days at standard refrigerator temperature, between 2 ° C and 8 ° C. Thereafter, the vaccine is administered at room temperature by patients. nurses.

If approved, the option to store between -25 ° C and -15 ° C for two weeks would be in addition to this five-day storage option at standard refrigerator temperature. Companies assure that they will present this data to other regulatory agencies around the world “In the next weeks“.

“If approved, this new storage option would give pharmacies and vaccination centers greater flexibility in managing their vaccine supply.. We are continually conducting stability studies to support the production of the vaccine on a commercial scale, with the aim of making the vaccine as accessible as possible worldwide, ”commented the President and CEO of Pfizer, Albert Bourla.

“Our top priority was to quickly develop a safe and effective vaccine and make it available to the world’s most vulnerable people to save lives. At the same time, we have continuously collected data that can allow storage at around -20 ° C. The data presented can facilitate the handling of our vaccine in pharmacies and offer vaccination centers even greater flexibility.», Underlined the CEO and co-founder of BioNTech, Ugur Sahin.

As more data on the stability of your vaccine becomes available, Pfizer and BioNTech expect the shelf life and / or expiration date to “could be expanded and the possibility of storing the vaccine at an alternate temperature in the short term could be considered“.

The first dose of Pfizer vaccine is 75% effective two weeks after administration.

An Israeli hospital study Sheba, released this Friday and published in the scientific journal The Lancet, showed that the first dose of the vaccine produced by Pfizer decrease in coronavirus infections by 75% at least two weeks after its administration.

The study is one of the first in the world to analyze the effectiveness of the first dose of the Pfizer vaccine, which was measured on the basis of a sample of just over 7,000 workers at the medical center where it was administered. been carried out.

The results showed low efficacy of the first dose in the first two weeks after administration but high efficacy after the first 14 days.

In addition to identifying a 75% decrease in the number of people who contracted coronavirus, the study also showed an 85% reduction in the number of people with symptoms of COVID-19.

According to the study, these data allow us to conclude that administration of the second dose may be delayed in countries with vaccine shortages, so that more people can be vaccinated.

However, its authors pointed out that further testing is needed, particularly focusing on the duration of effect of a single dose, before deciding whether a single dose policy is recommended.

“What we are showing is that a significant level of vaccination can be achieved even with a single dose,” he told the news agency. EFE Arnon Afek, director of Sheba Hospital and one of the study’s authors.

“Countries that need to vaccinate a large number of the population and do not have the logistical capacity to administer so many vaccines at the same time, such as the UK, have decided to start with a single dose and postpone the second to a higher percentage of the population is vaccinated, ”he added, indicating that this study provides scientific evidence to support this decision.

Regarding the sample used for this research, Afek admitted that although the number of people was not particularly high, the subjects studied were constantly and meticulously monitored, which was possible given that they all worked in the hospital, where they presented daily reports on your condition.

(With information from Europa Press and EFE)

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