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UK Regulator Revealed at Press Conference for Emergency Use Approval
Immune effect 22 days after receiving a blow … Lasts at least 3 months
Emphasis on “After a full review” … “Pfizer and AstraZeneca can be used for pregnant women”
The British government approved the urgent use of a new vaccine against coronavirus infection (Corona 19) developed in partnership with the University of Oxford and the multinational pharmaceutical company AstraZeneca on the 30th (local time).
The AstraZeneca vaccine has already started shipping the day before and is expected to be in full swing next week (4th).
Following the announcement of the use of the vaccine on the same day, the UK government announced that it is an independent regulatory body, the MHRA, the Joint Committee on Vaccination and Immunization (JCVI) and the Human Medicines Specialists Working Group of the Commission. Medicine Expert Working Group) held a press conference with experts involved in vaccine approval.
In particular, Sir Münir Pirmohamed, Chairman of the Working Group Committee, an expert in human medicine, introduced that the immunological effect increased up to 80% when the first dose and the second dose were separated by three months.
The content of the explanation related to the AstraZeneca vaccine at this day’s press conference was rearranged in a one-on-one format.
– This approved dosage regimen.
▲ MHRA Director Dr. Jun Lane said approval this time is a common way to give a dose of vaccine twice.
Previously, the AstraZeneca vaccine showed an average immune effect of 70.4% during the clinical trial.
However, in the first, only half the dose of the vaccine, and in the second, the full dose of the vaccine increased the prophylactic effect to 90%.
On the other hand, the prophylactic effect of those who administered the full dose at both times was 62%.
Dr. Lane explained that the low-dose regimen has not yet been fully explored.
– AstraZeneca vaccine targets.
▲ Dr. Lane said that the AstraZeneca vaccine has been approved for use by people 18 years of age and older.
In addition, he explained that the total dose of a serving is adjusted at 12-week intervals.
In this regard, Sir Münir Pirmohamed, chairman of the Committee of the Expert Working Group on Human Medicines, said that receiving the vaccine every three months would increase effectiveness.
Sir Pirmohamed said: “With an interval of three months between the first and the second dose, the (immunity) effect increased by up to 80%,” he said. “That is why we recommend this dose range.”
In the trial, he said, participants received two doses between weeks 4 and 26, and that data between weeks 4 and 12 “turned out to be the strongest.”
– Does it have an immunity effect even if it is hit once?
▲ Sir Pirmohamed said that the immune effect appears 22 days after receiving the AstraZeneca vaccine and lasts at least 3 months.
In addition, based on the analysis of the available data, he explained that the vaccine is also effective in the elderly.
However, he explained that additional data is needed to confirm this.
As a result of the data analysis, Professor Lim revealed that the effect was 70% from the 22nd day of vaccination.
Professor Lim said the second dose is still important, “because it can affect the duration of immunity.”
– Is the AstraZeneca vaccine effective against the mutant virus?
▲ Sir Pirmohamed said further research is needed to determine whether the vaccine reduces mutant infections.
“There is currently no data to show that a new variant in terms of vaccine effectiveness could render the vaccine useless,” he explained.
Dr. Lane says he is studying whether the new variant-related vaccine works and “will be available in a few days.”
– AstraZeneca vaccine safety issues.
▲ Dr. Lane emphasized that there is no omission or shortening regarding the approval process for the AstraZeneca vaccine and that it has undergone a comprehensive review.
Dr. Lane said he looked at all safety, effectiveness and quality data around the clock from the moment it became available.
Sir Pirmohamed added that the decision to approve the vaccine took a long time and the committee group reviewed the data.
– Priority of previously approved Pfizer vaccine and AstraZeneca vaccine.
▲ Professor Wei Shen Lim from JCVI explained that it is difficult to compare the results because there have been no tests comparing the Pfizer and AstraZeneca vaccines.
Therefore, the JCVI stated that one vaccine does not take priority over another at the stage of the primary vaccination program.
However, he said that logistical aspects such as vaccine transport and storage are important, and that vaccines can be preferentially administered to avoid wasting any vaccine in a specific area.
– The Pfizer vaccine has reported allergic side effects.
▲ Dr. Lane explained that there is growing evidence that the Pfizer vaccine has a very small risk even in people who have allergic reactions to food or other vaccines.
However, he cautioned that people allergic to any of the ingredients in Pfizer’s vaccine should not get vaccinated.
Dr. Lane also said that MHRA now believes that the Pfizer or AstraZeneca vaccines can be used for pregnant women or people who are breastfeeding if the benefits outweigh the potential risks.
/ yunhap news
