Right now, it seems as if the whole country has one question on their mind: when will life return to normal?
Unfortunately, the only way for life to return as it was a year ago will be if a vaccine gets approved.
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Here’s everything you need to know about the upcoming COVID-19 vaccine:
Is there only one COVID-19 vaccine?
There are currently two vaccines up for approval: one by Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH, and the other by Moderna Inc. Britain and Brazil are currently testing a third option, from AstraZeneca and Oxford University.
How will I know which vaccine to get?
According to Dr. Peter Marks and the FDA, you’ll speak with your healthcare provider to decide which vaccine is best for you. “It’s actually a wonderful thing that we have multiple vaccines in development, because it may be that some of the vaccines will work better in older people, some may be more effective in younger people, some may have fewer side effects in certain populations,” said Marks in an interview.
When will the FDA be discussing the available vaccines?
A Vaccines and Related Biological Products Advisory Committee Meeting will take place this week to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH. The meeting can be attended virtually.
A second meeting will take place on December 17 to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Moderna Inc. That meeting can also be attended virtually.
Has the FDA revealed anything about the vaccines?
According to a report by the FDA, the department is deeming Pfizer’s vaccine safe and over 90% effective across patients of different ages, races and underlying health conditions. The FDA has specifically confirmed it works well in older people, who are especially vulnerable to the virus.
How do vaccines work?
According to the FDA, vaccines work by mimicking infectious bacteria or viruses that cause disease. The vaccination stimulates the body’s immune system to build up defenses against the infectious bacteria or virus without causing the disease. Vaccination exposes the body to the parts of infections that the immune system recognizes as foreign to the body, also known as antigens. After vaccination, the immune system is prepared to respond quickly and forcefully when the body encounters the real disease-causing organism.
Why are we getting this vaccine so quickly?
In public health emergencies, such as a pandemic, the development process may be atypical or expedited. In a response to the coronavirus pandemic, the US government combined government agencies, international counterparts, academia, nonprofit organizations, and pharmaceutical companies and had them work together to develop a coordinated strategy for prioritizing and speeding development of the most promising treatments and vaccines.
Is the vaccine safe?
According to Dr. Peter Marks, there will be no change in standards for vaccine approval. Due to Operation Warp Speed, multiple steps of vaccine testing are being done simultaneously in the hopes of not sacrificing the safety or the determination of efficacy in order to be able to produce a vaccine for use more quickly.
Will it provide herd immunity?
The FDA is hoping that if enough people get vaccinated, we can create herd immunity. Herd immunity is the idea that when you have enough people in the population that are vaccinated and immune, the disease has nowhere to go if it shows up.
What is the process to get a vaccination approved?
Vaccinations must begin in a lab. Considered the Research and Discovery Stage, scientists must conduct laboratory research to test their ideas. If the vaccine seems like it could work, it must move on to the preclinical phase — testing on animals. When the vaccine is ready to be tested on humans, all information pertaining to the manufacturing technology and the quality of the vaccine must be submitted to FDA in the form of an Investigational New Drug application (IND). The FDA also conducts an assessment of the product, its quality and safety, and the technology to manufacture it, to determine whether it is reasonably safe for testing of the vaccine to move forward in people. Clinical trials are then conducted in different phases.
Phase 1 – Emphasis during this phase is on safety and generally includes 20–100 volunteers who haven’t been exposed to the disease being studied and who are generally otherwise healthy. These studies are used to determine whether there are adverse reactions with increasing doses and, if possible, to gain early information about how well the vaccine works to induce an immune response in people.
Phase 2 – In the absence of safety concerns from phase 1 studies, phase 2 studies include more people, where various dosages are tested on 100’s of people with typically varying health statuses and from different demographic groups, in randomized-controlled studies. These studies provide additional safety information on common short-term side effects and risks, examine the relationship between the dose administered and the immune response, and provide initial information regarding the effectiveness of the vaccine in its ability to generate an immune response. Standardized and validated tests are used to evaluate the immune responses. These vaccine studies typically also include a control group consisting of people who may receive an FDA-approved vaccine, a placebo or another substance. People receiving the vaccine under study are compared to people in the control group.
Phase 3 – The vaccine is generally administered to thousands of people and the study generates critical information on effectiveness and additional important safety data. This phase includes additional information about immune response and compares those who receive the vaccine to those who receive a control, such as a placebo. For example, the number of cases of disease in the vaccinated group is compared to the number in the control group to see whether the vaccine reduces the incidence of disease. These studies also provide information about the vaccine’s safety including the identification of less common side effects.
Once it’s confirmed that the vaccine can be produced reliably and consistently, and the preclinical and clinical development programs have been successfully completed, companies submit a Biologics License Application (BLA) to the FDA. The BLA includes preclinical and clinical data and information, as well as details of the manufacturing process and facility. By submitting a BLA to the FDA, a company is seeking permission to distribute and market a vaccine for use in the United States. If FDA approves the vaccine, the company is permitted to market it in the United States for use in the population for which it is approved.