New Delhi. In the US, since July, Coronavirus infection is being termed as an epidemic of people who have not vaccinated (Coronavirus Vaccination), due to the spread of infection, people’s inability to get the vaccine (Vaccine Hesitancy) is also attributed. He is going. Vaccination figures have come to a standstill after the rapid introduction of vaccination in the US earlier this year. In such a situation, to promote vaccination, the US drug regulator has decided to give formal approval to the mRNA vaccine of Pfizer BioNtech. The American Drug Regulator (USFDA) believes that this will speed up vaccination and will also dispel the misconceptions about the vaccine.
What is meant by formal approval?
Most of the vaccines that have been approved so far for corona infection have been approved for emergency use. Vaccine development took many years before the pandemic, but the corona virus infection changed that. Scientists developed, trialled and released the vaccine in record time. However, this does not mean that any compromise has been made on the safety and effectiveness associated with the vaccine. The vaccine has been approved on a priority basis, so that the crisis of the epidemic can be countered.
Acting Commissioner of the US Food and Drug Administration, Janet Woodcock, said, “Pfizer and other vaccines have followed stringent FDA standards, after which they were approved for emergency use. When the first FDA-accredited vaccine hits the market, people will be confident that the vaccine has met stringent standards, is effective, and has been manufactured following FDA protocols.”
Woodcock said that getting the vaccine formally approved will instill confidence in the people about vaccination. He said that this will further help in stopping the epidemic. Let us tell you that US President Joe Biden is constantly appealing to his people to get vaccinated. He has appealed to companies and organizations to vaccinate their staff, as well as to make vaccination mandatory for 1.3 million active soldiers of the US Army.
How is formal approval different from emergency?
According to the World Health Organization, any medical product is approved for emergency use when the disease threatens human life and there is a possibility of infection turning into an epidemic. All these things apply in the case of corona infection. According to health experts, humans had never encountered this virus, so the vaccine was the biggest medical solution to control the epidemic. In such a situation, governments and companies put full force in the development of the vaccine and the vaccine was developed in record time.
However, companies that get approval for emergency use have to follow all the procedures for formal approval, so that the medical product can be launched in the market. According to WHO, once a product is included in the emergency list, as far as possible, the company should follow all the processes related to product manufacturing and its development in order to get marketing approval.
How Pfizer got emergency use approval
In December last year, the Pfizer vaccine was approved by the US FDA. Pfizer’s vaccine was the first to get this approval. The FDA approved it on the basis of randomized, controlled and clinical trials conducted on thousands of people. Pfizer’s vaccine could be given to people above the age of 16 under emergency use, later this vaccine was also approved for children above 12 years. But, the formal approval of the vaccine has been kept for people above 16 years.
However, under emergency use, the vaccine can also be given to children aged 12 to 15 years. Also, people with weak immunity can also be given the third dose of the vaccine. The Pfizer vaccine is a two-dose vaccine with a three-week gap between the two doses. The FDA has said that Pfizer’s vaccine has been tested on 22 thousand people. The people involved in the trial were over 16 years of age, while those involved in the clinical trial were kept under medical supervision for four months after the second dose of the vaccine.
Why are people not getting vaccines in America?
In the US, more than three million doses of vaccine were given to people in mid-April, since then there has been a steady decrease in the number of vaccinations. Meanwhile, the number of cases of corona infection was close to 10 thousand per day at the end of June, which has increased to 1 lakh by August. According to a survey conducted in the US at the end of June, 31 percent of those who had not been vaccinated said that they would get the vaccine only when it was approved for formal use, while 49 percent said they would prefer to wait and see. What is the effect of the vaccine?
Pfizer’s vaccine has been found to be 90 percent effective in clinical trials.