They started testing it on pregnant women
New data from "Pfizer" and "Biontech" about the possibility of easing the requirements for keeping their vaccines
A Colombian health worker receives the Pfizer / Bionic vaccine.
A.F.B.
Young men indicated the need to strongly increase the frequency of vaccinations.
EPA
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Yesterday, Pfizer and its partner Biontech submitted new data to the US Food and Drug Administration about the temperature needed to store their Covid-19 vaccine, and said that the data may allow storage at normal temperatures in refrigerators and freezers in pharmacies, while they begin testing Their vaccine against "Corona" is applied to pregnant women.
In the event that new data from Pfizer and Biontec are approved, easing the requirements will significantly reduce the transportation and storage burdens, as the vaccine must now be stored at minus 70 degrees Celsius, which represents a particular challenge in low-income countries. Does not have the infrastructure needed to store in extremely cold temperatures.
The Pfizer / Bionic vaccine, along with Moderna's vaccine, has been approved for emergency use in the United States and is being widely distributed as part of the nation's comprehensive vaccination efforts.
The new data was submitted to the US Food and Drug Administration to support a proposed amendment to the Emergency Use License recommendations, allowing packages to be stored at between minus 25 degrees and minus 15 degrees, for up to two weeks in total as an alternative to storage in ultra-low temperature refrigerators. .
The CEO of Biontech, Ujur Shaheen, said, "The data provided may facilitate the circulation of our vaccine in pharmacies, and give vaccination centers greater flexibility."
The two companies said that the new data will also be submitted to global regulators within a few weeks.
"Biontech" and "Pfizer" began a large study of the vaccine trial on pregnant women, and the two companies announced, the day before yesterday, that the study aims to determine the safety, tolerability and efficacy of the vaccine for pregnant women.
Pregnant women and children are often excluded from vaccination recommendations so far, due to the lack of reliable data and the lack of relevant studies.
It is scheduled to test the vaccine in phase 2/3 of clinical trials on about 4000 pregnant women who are in good health, over the age of 18 years.
They are scheduled to be given vaccinations between week 24 and 34 weeks of pregnancy.
Participants will be randomly divided into two groups: one receiving the real vaccine, and the second receiving a placebo vaccine.
"Our goal is to provide broad access to our highly effective vaccine against (Corona)," said the medical director and co-founder of Biontech, Ozlem Turishi, explaining that after the vaccination campaigns began, it is time to expand them to include other groups more vulnerable to infection such as pregnant women, "In this way, pregnant women, as well as future generations, can be protected," she said.
Within the framework of the study, pregnant women will be monitored for a period of up to 10 months, during which the safety of the vaccination for infants will be examined, and the transmission of antibodies that may be protective for children, according to the two companies' statement.
The statement indicated that the children will be followed up until they reach six months of age.
Mothers who received a placebo vaccine during pregnancy will be informed after delivery, so that they can receive the vaccination.
And William Gruber, head of clinical studies and development at Pfizer, said, "Pregnant women are more at risk of developing complications and a severe course of (Corona), so it is very important to develop a safe and effective vaccine for this population."
The two companies are already testing the vaccine in teenagers.
In addition, a study of children between the ages of 5 and 11 will begin in the next few months, according to the statement.
Clinical studies on vaccinations for particularly high-risk groups, such as pregnant women and children only, usually begin after successful completion of similar studies with adults.
This comes at a time when a study conducted on medical staff in an Israeli hospital revealed that the first dose of the "Pfizer" vaccine against "Covid-19" is 85% effective in preventing the disease, which may spark controversy over the two-dose vaccination plan, And recommended in light of the efforts of governments to increase the distribution of vaccines.
The results, which were concluded by Sheba Medical Center, are compared with an efficiency of approximately 95% in the two-dose vaccination system, separated by 21 days, with the vaccine developed by "Pfizer", in cooperation with "Biontech".
This study, which will be published in the Lancet medical journal, came a day after Canadian researchers reported postponing the second dose of the "Pfizer" vaccine, due to the high level of protection provided by the first dose, so that larger numbers can be vaccinated.
German Health Minister: "Corona" will not give up easily
German Minister of Health, Jens Young, called again for caution in light of the development of the numbers of Coronavirus cases.
"The virus will not surrender easily," the minister said yesterday in Berlin, indicating that in addition to the worrisome mutations, there is currently a deviation regarding the decrease in the numbers of new infections.
Young people expressed his understanding of the need to end the closure, stressing on the other hand the need to exercise caution and caution when taking such a step, so that what has been achieved is not endangered.
The minister also indicated the need to strongly increase the frequency of vaccinations, and to use rapid tests and self-tests, on a large scale, starting next March.
According to data from the German Robert Koch Institute for Disease Control, the rate of disease prevalence per 100,000 people within seven days, yesterday, reached 56.8 injuries.
The highest rate was recorded on December 22, with 197.6 injuries.
In the previous days, there was no significant decrease in the rate of the past seven days.
The federal and state governments seek to reduce the rate to less than 50 injuries.
The authorities do not intend to take large-scale steps to reopen, except when the rate drops to less than 35 injuries.
Berlin - D.A.
The
two companies will start studying the vaccine on children between the ages of 5 and 11 years, in the next few months.
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