COVID vaccine in final approval stages


Georgia department of public health

The COVID-19 vaccine is expected to be available before the end of the month and will be administered to hospital workers first.

The FDA has deemed Pfizer’s COVID-19 vaccine to be safe, as of December 8, which is a main hurdle to begin being administered in the 40 million vaccines which will be available in the US by the end of the calendar year.
The Food and Drug Administration (FDA) has guidelines and rules set in the approval process of any vaccine.
“We have an oversight committee from the FDA that looks at the data and sets up a meeting of experts, the FDA Advisory Committee. This consists of epidemiologists and infectious disease people, they sit in a building along with company executives and company scientists and they go through the data, slide by slide where you can see the graphs, the side effects, which people fell out, the age group being tested, etc,” Dr. Bob Lahita stated in an interview with CBS news.
Before obtaining FDA approval, biopharmaceutical companies like Pfizer need to test their product on multiple people. Currently, only people the age of 18 and over can receive the potential COVID-19 vaccine, because it has not yet been tested in children.
“Children’s immune systems are very different from adults’, and their immune responses can be different at different ages, from infancy through teenage years,” the Connecticut Children’s Medical Center stated.
With that information at mind, Pfizer’s Covid vaccine has only been fully tested on adults, and is beginning to include teenagers as young as 16 in the on-going trial.
The United Kingdom administered its first vaccines to its citizens on December 7, and the US is not far behind. Currently, there are only two vaccines that have received temporary authorization in the UK but many others are in the process.
“Few vaccines have been authorized to date. Pfizer/BioNTech’s BNT162b2 received temporary authorization from the UK Medicines and Healthcare products Regulatory Agency on 2 December,” stated by the Regulatory Affairs Professionals Society.
The FDA is giving emergency authorization to target health care workers to receive the first doses. Recommended by the CDC, there are certain groups of people that need to get the vaccine first, those being healthcare personnel and residents of long-term care facilities.
“Healthcare personnel is defined as paid and unpaid people serving in healthcare settings who have the potential for direct and indirect exposure to patients or infectious materials,” the CDC said. “Long-term care facility residents are defined as adults who reside in facilities that provide a variety of services, including medical and personal care, to persons who are unable to live independently.”
A lot of decisions still need to be made, but with the possibility of a limited supply of the new vaccination, the Advisory Committee of Immunization Practices (ACIP) considered four groups to have the possibility of receiving it first.
“Healthcare personnel, workers in essential and critical industries, people at high risk for severe COVID-19 illness due to underlying medical conditions, and people 65 years or older,” the ACIP stated.
According to USA Today, currently the US government and Pfizer disagree on how the available 40 million vaccines should be distributed. The government plans to deliver the vaccine to 20 million people in the full two-shot dose, while Pfizer feels doses should be given to as many people as possible, with the understanding that they will produce the second dose of the vaccine soon.

Producing a vaccine is a complicated process, with a lot of minor details that have to be exactly correct for it to work properly.
“At the end of the day, that’s really what you want: a vaccine that not only is efficacious but also is safe,” Dr. Jennifer Pancorbo stated in an interview with Channel 7 news.
So much goes into making a safe vaccine, many things the public eye does not see.
“At least 165 candidate vaccines for the SARS Cov-2 virus (COVID-19) are in development around the world,” stated in a report from The John Hopkins Center for Health Security.
There are many rules and special guidelines scientists and workers must follow when working on the vaccine.
“All approaches to allocation that are legally and ethically valid in the expert judgment of the project team should be considered, even if not all are eventually included,” stated in a report from John Hopkins Center.
It has been almost a year into this pandemic and scientists from all over the world have been working to come up with a vaccine to treat COVID-19.
“Most people infected with the COVID-19 will experience mild to moderate respiratory illness and recover without requiring special treatment,” the World Health Organization stated in their overview. “Older people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness.”