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Second after Modena … Pharmaceutical products can be sold for one year with prior approval
Pfizer’s first vaccination country appears to be the UK … as early as the 7th
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The US pharmaceutical company Pfizer and Germany’s Bioentech have requested approval for the marketing of a new vaccine against coronavirus infection (Corona 19) from the European Medicines Agency (EMA). If the approval process goes as planned, vaccination is expected within this month.
On 1 (local time), according to Germany’s Suddeutche Chaitung (SZ), Pfizer and Bioentech submitted an application for the approval of the Corona 19 vaccine to the European Medicines Agency after the US pharmaceutical company Modena the day before.
If the European Medicines Agency initiates a review and approves it, the two companies will be able to start their first vaccination in December, SZ predicted. European Union (EU) conditional sale approval is a procedure for responding quickly to emergency situations that threaten public health such as Corona 19. The drug can be marketed for one year in 27 member states before all are available. the necessary information on its effectiveness and side effects.
Pfizer-Bioentech previously announced the final results of a Phase 3 clinical trial that the immune effect of the COVID-19 vaccine jointly developed by the two companies was 95%, and therefore requested emergency use of the vaccine at Food. and US Drug Administration (FDA) on the 20th of last month. done. On the 30th of last month, Moderna initiated a procedure for the emergency use of the Corona 19 vaccine in the United States and Europe simultaneously. Moderna revealed that the final analysis of its Phase 3 clinical trial on the vaccine showed it had a preventive effect of 94.1%. Of the pharmaceutical companies that recently announced the results of the Corona 19 vaccine clinical trial, Pfizer, Biontech and Modena are the most advanced in the approval application process.
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The UK will be the first country in the world to receive the Pfizer vaccine. The Daily Financial Times (FT) reported that the UK will vaccinate Pfizer’s Corona 19 vaccine as early as the 7th. FT quoted a government official as saying that the independent regulatory agency, the Drug and Health Care Products Regulatory Authority (MHRA ), could approve the Pfizer-Bioentech vaccine as soon as possible this week. The UK has decided to first secure 40 million vaccines from Pfizer, which can be administered twice by 20 million people, a third of the population.
British Prime Minister Boris Johnson has also appointed Nadim Jahawi as Deputy Minister of Government Affairs, Deputy Immunization Minister. Deputy Minister Jahawi will focus on vaccine distribution and vaccination under the leadership of British Health Secretary Matt Hancock. The Prime Minister’s office explained that Deputy Minister Ja Ha-wi’s work is temporary and will continue at least until next summer.
Moreover, Japan, which has secured Pfizer and Modder vaccines, is also accelerating. According to the Nippon Geizai Shimbun, the Japanese Ministry of Health, Labor and Welfare has decided to consider applying a special procedure to shorten the approval process with the aim of starting vaccination by this year. Additionally, Malaysia managed to obtain 12.8 million doses of Pfizer vaccine for the first time in Southeast Asia.
It was later revealed that Pfizer was negotiating with the Philippines and other US allies over the sale of the Corona 19 vaccine. Philippine Ambassador Jose Manuel Romualdez, CNN Philippines, said on 9 last month that “Pfizer will set a reasonable price for allies of the United States, including the Philippines. He said: “In a country like Korea (Philippines), (Pfizer) won’t sell it dearly,” he said, adding that the price could be set at around $ 5 per dose of the vaccine.
Pfizer’s COVID-19 vaccine, known to have a 95% preventative effect, is rated as the most effective vaccine among pharmaceutical companies in the world. However, the price of a vaccine is 19.5 dollars (about 21,000 won), which is much more expensive than AstraZeneca (3 ~ 5 dollars). In particular, the Pfizer vaccine is relatively expensive as it requires two doses per person. Remarks by Ambassador Romualdez suggest Pfizer could sell the vaccine to allies at a lower price than it currently does.
Ambassador Romualdehydes said Pfizer continued to keep in touch with the Philippine Ministry of Health and Food and Drug Administration, discussing how the two governments could conclude the negotiations. As a result, he explained that the Pfizer vaccine will be delivered to the Philippines within the first quarter of next year. President Calito Galvez, advisor to the President’s Office, which leads the Corona 19 Task Force (TF), also explained that on November 23 he is negotiating with Pfizer and China’s Sinovac on the supply of vaccines.
/ Reporter Kihyuk Kim [email protected]
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