Pfizer and BioNTech Announce Vaccine - Coronavirus COVID-19: Vaccine, Drug and Treatment - Pfizer vaccines Covid-19

Biotech and Pfizer Corona Vaccine

 In United States, Pfizer wants permission for the use of new virus vaccine in emergency condition.

Detailed information on corona vaccine test released by major manufacturers-Aiming to improve transparency

US pharmaceutical giant Pfizer and Germany's Biotech have applied to the US Food and Drug Administration (FDA) on the 20th for an emergency license to use the new coronavirus vaccine under development. In United States, it is the first emergency license application for a new virus vaccine.

The FDA will determine the safety of Pfizer and Biotech vaccines. It's unclear how long it will take to evaluate the data, but the US government expects emergency use to be approved in early December.

Phase 3 of a Pfizer vaccine clinical trial has shown that it protects 94% of vaccinated people over the age of 65.

The UK has reserved 40 million supplies and is expected to secure 10 million by the end of the year.
In the United States, where the death toll from the new virus exceeded 250,000, the number of deaths per day exceeded 2,000 for the first time since June on the 19th. Under these circumstances, the need for vaccines became clear again.

When will the vaccine be available?

With FDA approval early next month, Pfizer and Biotech said they would be "ready to distribute vaccine candidates within hours of approval."

The emergency license application for the new virus completed and the genetic code of new virus revealed in first 10 months. This is surprisingly fast for vaccine development. It is estimated that it will take an average of nearly eight years for the vaccine to be approved in the United States. Pfizer's CEO Albert Bourla said yesterday that the application for an emergency license was "a milestone in our efforts to deliver the COVID-19 (new virus infection) vaccine to the world."

However, the initial supply is expected to be negligible, and the first vaccination target will be decided by the US Centers for Disease Control and Prevention (CDC).

European Commission Chairman Ursula von der Lyen said he would take immediate action to approve the vaccine in Europe later this year.

However, there are several caveats to vaccine approval. Stephen Evans, a professor of drug epidemiology at the London School of Hygiene and Tropical Medicine, said both the FDA and the European Medicines Agency (EMA) should "consider very carefully."

The BBC's health correspondent, Naomi Grimley, said the vaccine has a long way to go before it becomes widespread, especially as it employs experimental techniques that have never been approved in the past. Point out that.

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The effect of the vaccine

Data released this week show that the vaccine being developed by Pfizer and Biotech is 95% effective. It was also found to be effective for all age groups, ethnicities, and genders. The side effects of this vaccine were mild to moderate and temporary.

Pfizer and Biotech vaccines have been developed by experimental methods that train the human immune system by injecting a portion of the viral genetic code called mRNA.

Inoculation with this vaccine produces antibodies against the new virus and activates T cells that destroy infected cells.

The status of infection in the United States

In the United States, the death toll from the new virus exceeded 250,000, the highest number in the world, on the 18th.

According to the data of Johns Hopkins University in the United States, the cumulative number of infected people in the country since the start of the pandemic is 11,895,876, which is also the highest in the world (as of the morning of 21st Japan time).

The number of infected people and deaths in the United States has skyrocketed in the past week.

What other vaccine development is there?

Modena, a US biotechnology company, announced on the 16th that it has obtained initial data showing the effectiveness of the new virus vaccine under development, which is close to 95%. This vaccine also uses mRNA.

In terms of development, Modena does not appear to be far behind the Pfizer and Biotech vaccines.

The vaccine being developed by Oxford University in the UK and AstraZeneca, a major pharmaceutical company in the UK, is still in clinical trials, but it has been shown to have a strong immune response in the elderly. The UK has ordered 100 million supplies. Corona Virus  vaccine was derived from a weakened version of a common cold virus (called adenovirus) taken from chimpanzees as a sample. It has been changed so that it does not infect humans.

A clinical trial of a Russian vaccine named "Sputnik V" has shown similar promising results. Russian vaccines have the same effect as Oxford vaccines.

In addition, several other vaccines are in the final stages of clinical trials in China and Russia.

Determine final candidate for mRNA vaccine

The mRNA vaccine candidates developed by Pfizer and Biotech are BNT162b1 and BNT162b2.Non-clinical and clinical trials evaluating four BNT162 RNA vaccine candidates, two of which are promising candidates based on the evaluation of safety and immune response. It was shown to be.

In nonclinical studies, BNT162b1 and BNT162b2 elicited good viral antigen-specific CD4 + and CD8 + T cell responses, showed high neutralizing antibody activity in a variety of animal species, and the SARS-CoV-2 challenge in monkeys. The study showed a beneficial preventive effect. In addition, the two companies will analyze nonclinical and Phase 1/2 study data in detail and, in consultation with the US Food and Drug Administration's Center for Biopharmacy Evaluation and Research (CBER) and other regulators, the 2nd. BNT162b2 was selected as a candidate for evaluation in the three-phase study.