“So very quickly we get more than 150 million servings a month in March, April, May,” he added. He and other federal officials said the general public is likely to be able to vaccinate themselves by May or June.
Are all the terms used to describe the function and testing of vaccines confused? Let’s help:
- Adverse event: A health problem that occurs in volunteers in a clinical trial of a vaccine or drug. An adverse event is not always caused by the treatment tested during the study.
- Antibody: A protein produced by the immune system that can attach to a pathogen, such as the coronavirus, and prevent cells from becoming infected.
- Approval, authorization and emergency use: Drugs, vaccines, and medical devices cannot be sold in the United States without obtaining them approval from the Food and Drug Administration, also known as licensing. After a company submits the results of clinical trials to the FDA for consideration, the agency decides whether the product is safe and effective, which usually takes months. If the country is facing an emergency, such as an epidemic, a company can apply for emergency use permit, which can be entered much faster.
- Background ratio: How often a health problem, called an adverse event, occurs among the population. To determine if a vaccine or drug is safe, researchers compare the rate of adverse events that occurred during the study with the background.
- Efficiency: Measuring the effectiveness of treatment in a clinical trial. For example, to test for a coronavirus vaccine, researchers are comparing how many people in the vaccinated and placebo groups receive Covid-19. It may turn out that the actual effectiveness of the vaccine differs from that of the study.
- Phase 1, 2 and 3 experiments: Clinical trials are typically conducted in three phases. Phase I studies usually involve a few dozen people and are designed to monitor whether the vaccine or drug is safe. Phase 2 research involving hundreds of people will allow researchers to try out different doses and gather additional measurements of the effect of the vaccine on the immune system. Phase 3 studies, involving thousands or tens of thousands of volunteers, determine the safety and effectiveness of a vaccine or drug by looking at how many people are protected against the disease they are fighting.
- Placebo: A substance that has no therapeutic effect is often used in a clinical trial. To determine if a vaccine can prevent Covid-19, researchers can give the vaccine to half of their volunteers, while the other half receive placebo from salt water. They can then compare how many people from each group become infected.
- Post-market monitoring: Post-approval check of a vaccine or medication that is regularly prescribed by doctors. This observation usually confirms that the treatment is safe. In rare cases, you may experience side effects that have been missed in clinical trials in certain groups.
- Preclinical research: Pre-clinical trials, which usually involve experiments where the treatment is tested on cells or animals.
- Virus-vector vaccines: A vaccine that uses a harmless virus to drive the driver’s immune-boosting ingredients into the human body. The viral vector is used in a number of experimental Covid-19 vaccines, including those developed by AstraZeneca and Johnson & Johnson. Both companies use a common cold virus, called an adenovirus, as a vector. Adenovirus carries coronavirus genes.
- Trial protocol: A set of procedures to be performed during a clinical trial.
The CDC board should initially have voted on its recommendations only after the FDA approved the vaccine. But it clashed with the timing to give states more guidance in preparing their distribution plans, which are due to be submitted to the CDC on Friday.
On Tuesday, the group specifically recommended that residents of nursing homes among the long-term care population, who are generally the most fragile and susceptible to Covidra, receive the first vaccinations if there are not enough workers with no virus in the past 90 days.
Within the much larger category of health workers, the panel says health systems should consider the priority of those who have direct contact with patients and their families, as well as those who handle infectious substances. Dr. Nancy Messonnier, who heads the CDC’s National Center for Immunization and Respiratory Diseases, told the panel that based on her recent conversations with state health officials, most states and cities “believe she can vaccinate all of her health workers within three weeks. . “
But whether they achieve that goal depends on how much vaccine they receive and how quickly. Kentucky Gov. Andy Beshear told reporters on Monday that his state has more than 200,000 health workers, but will only receive 38,000 doses in its first shipment and may not receive another for two weeks.
Long-term care facilities include nursing homes with a population of about 1.3 million; supported residences with 800,000 inhabitants; and residential care facilities, which are generally small and serve specific populations. The federal government has entered into an agreement with CVS and Walgreens to supply vaccines to most of these facilities nationwide, with pharmacist groups making three visits to each to ensure that all employees and residents receive an initial and one week later booster dose at the same time. .
Several members of the board urged that the offices of small community physicians should not be left out of the initial priority list. “Transmission dynamics suggest that providers who care for patients earlier in their illness may be at greater risk,” said Dr. Jeffrey Duchin, a board member in charge of public health in Seattle and King Wash County.