Summarize the vaccine: how long, how effective and who gets it first

The U.S. Food and Drug Administration (FDA) protects public health by ensuring the effectiveness and safety of biological products, including foods and medicines, such as vaccines. This means that for any vaccine to be approved for distribution to the American public, it must first be approved by the FDA.

The specific area of ​​the FDA that deals with vaccines is the Center for Biologics Evaluation Research (CBER). This center regulates biological products using a series of regulatory measures, such as the Public Health Services Act and the Food Medicines and Cosmetics Act.

The process of creating a vaccine is historically long. It starts with scientists and researchers identifying the antigen, which is the part of a germ that the immune system can recognize and attack to prevent the target disease.

Vaccines work by stimulating an immune system reaction. They do this by essentially inducing the body to think there is an infection. Although the body may occasionally show minor symptoms of infection after vaccination, the type of pseudo-infection introduced by the vaccine almost never causes disease.

Total pathogen vaccines are the traditional type of vaccine. These vaccines contain entire pathogens that have been killed or weakened enough to not cause disease. Because they have whole pathogens, they elicit strong immune responses. However, not all diseases can be targeted with this type of vaccine.

Unlike a complete pathogen vaccine, a subunit vaccine uses only antigens to better stimulate the immune system. This vaccine project is safer and easier to produce, but often requires the addition of adjuvants, components that induce a stronger immune response, because the antigens are not sufficient on their own for long-term immunity.

Nucleic acid vaccines use genetic material to encode the antigen or antigens needed to produce an immune response in the body. This allows the body’s own cells to produce the antigen (s) using the genetic material. The advantages of this type of vaccine are the long-term immune responses, the scalability and stability of the vaccine. Some of these vaccines are based on mRNA (messenger DNA). Both Pfizer / BioNTech and Moderna coronavirus vaccines use mRNA.

Some vaccines require more than one dose. There are a few reasons for this. Some vaccines do not provide much immunity at the first dose and therefore need more. In others, immunity disappears over time and “booster” doses are needed. In some live vaccines, multiple doses make it more effective. And in the case of the flu vaccine, a new dose is needed every year because the flu virus that causes the disease varies from year to year.

Before starting the application of a new investigational drug (IND), a vaccine must be screened for the potential danger to animals. These occur through animal pharmacology and toxicology studies, taking preclinical data to allow an assessment of whether the product is safe enough to begin testing in humans.

Once the screening for potential danger to animals is completed satisfactorily, the vaccine passes through IND. IND allows the vaccine sponsor to obtain permission from the FDA to distribute the vaccine between states to clinical investigators. At that point, the molecule used in pharmacological activity legally changes to a new drug.

When a sufficient number of human participants is found, the new potential vaccine is subjected to a randomized clinical trial, in which people in the group are assigned to a control or experimental group. The experimental group receives the vaccine, while the control group receives the placebo. Neither the people themselves nor the researchers know which group the participants are in. This does away with prejudice, and it is only at the end of the study that researchers and participants find out who was in which group.

During phase 1 of the clinical trial, the first participants receive the vaccine under test. The objectives of this phase are to assess the safety of the vaccine and its ability to produce the desired immune responses. It is often during this phase that the mode of administration of the vaccine and the immunization schedule (how often it should be applied) are also assessed.

Once a trial has results, these results must be reviewed by peers. This means that expert scientists review the data to make sure it is correct and reproducible. There have already been several COVID-19 candidate vaccines where phase 1 and 2 trials have resisted peer review.

through financial investment and, therefore, stricter stop-and-go policies are observed by drug developers.

After the drug has successfully performed in phase 2, it moves on to the main phase 3 trials, which are essential for the registration and market approval of a vaccine. These are designed to assess effectiveness and safety. These large-scale clinical trials involve thousands of individuals and are conducted under conditions that will be similar to future routine use of the vaccine.

While much attention has been paid to breaks in clinical trials of the COVID-19 vaccine, these breaks are actually signs that the system is working and science is progressing as it should, not that vaccines are dangerous. Since vaccines are given to completely healthy people, there is a high standard for trials that test vaccines to ensure they are completely safe. Therefore, if a test participant becomes ill for any reason during the test, the test will be paused to examine the cause of the disease.

An interim analysis is made as the trial progresses to assess the vaccine’s effectiveness. To make an intermediate analysis, there must be sufficient cases of the disease among the participants to analyze the percentage that occurred in the control groups compared to the vaccinated group. Moderna’s most recent COVID-19 candidate vaccine showed a 94% success rate in its interim analysis, with only five of the 95 cases of COVID-19 occurring in the vaccinated group.

articles / PMC5024796 / “> Bioethics in practice: Considerations for terminating a clinical trial early,“ The early termination rule has the potential to minimize harm and maximize benefits for patients enrolled in a randomized clinical trial. ”

A BLA (Biologics License Application) is required to obtain permission to insert a biological product in interstate commerce. This application requires information from the applicant, which can be any legal person or entity involved in manufacturing, along with product information, pre-clinical study information and labeling.

The FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) sets the regulatory path for allowing the large-scale use of a vaccine and can delay the process when necessary. In late October, VRBPAC held a virtual nine-hour meeting to discuss the regulatory path, at the end of which it told the FDA to slow down the process of trying to get a COVID-19 vaccine so quickly.

Before a vaccine can be used in the United States, the FDA must conduct a manufacturing investigation, where scientists and medical professionals investigate how the vaccine is manufactured to make sure it can be made in a consistent, safe, pure and potent manner. This includes inspecting manufacturing sites to ensure that they comply with regulations.

especially destructive diseases, like COVID-19, some may find that it doesn’t move fast enough. In this case, there is the possibility of making the vaccine available more quickly, through

FDA emergency use authorization.

Emergency use authorization (USA) allows the FDA to make unapproved products, such as drugs or vaccines, available for use in public health emergencies. However, a USA has never been used to administer a vaccine to civilians. This is because, although drug treatments are generally given to people who are already sick, vaccines are given to people who are still healthy, so the barrier to using them is much greater. In the case of COVID-19, the FDA has been considering criteria for implanting a vaccine initially under the United States.

Although vaccines themselves are vital, they are only useful when they can reach the people who need them. That’s where the vaccine supply chain comes in. Providing vaccines to millions of people requires effective handling, storage and stock management, as well as strict temperature control and well-maintained information systems.

In the case of COVID-19, the severity of the virus makes it especially important to get the vaccine to as many people as quickly as possible. In the United States, states are already developing vaccine distribution plans, addressing vaccine storage issues, tracking data and seeing who will pay for the vaccine to be implanted and how to ensure it is done equitably.

nbcnews.com/think/opinion/getting-covid-19-vaccine-market-will-be-hard-getting-americans-ncna1237753″> scientific skepticism and disinformation are making people suspicious of the COVID-19 vaccines that are coming come over.

Also known as a phase 4 trial, post-marketing surveillance is done when the drug is already on the market and is available to the general public. This phase checks the vaccine’s performance in real-life settings, studies the long-term risks and benefits, and potentially reveals rare side effects.

In the event of an adverse reaction to a vaccine, the CDC and the FDA co-manage the Vaccine Adverse Event Reporting System (VAERS). This national early warning system accepts and analyzes reports of possible negative side effects after a person has received the vaccine. Anyone can report to VAERS.

Herd immunity occurs when a virus stops spreading because it continually finds people protected from infection. This is the ultimate goal of large-scale vaccination programs. In this case, the vaccine protects those who are vaccinated and herd immunity protects those who cannot be vaccinated, for example, those with compromised immune systems. Unvaccinated people become less vulnerable, because the chances of coming into contact with an infected person are drastically reduced.

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