Download COVID Vaccine Assignment for the biology class and more Assignments Biology in PDF only on Docsity!
Several companies have developed a vaccine for COVID19.
- Use the internet to research one of the COVID19 vaccines that is either in use or under development then answer the following questions: a. What is the name of the company that is developing or has developed the vaccine you are researching? b. What type of vaccine is it? (live attenuated, subunit, DNA, RNA?) c. How the vaccine is prepared. c. How will the vaccine stimulate the immune system to provide immunity? e. Is the vaccine FDA approved? If the vaccine is FDA approved when did it get FDA approval? If the vaccine is not FDA approved, what stage of development is the vaccine in? Note: There is a difference between FDA emergency approval and full FDA approval. Explain the difference and what stage the vaccine is in.
- Based on what you have learned from your research do you think the vaccine will provide immunity (a vaccinated person can not get COVID19 and cannot transmit COVID19) or do you think the vaccine will just lesson the severity of the disease in individuals but vaccinated individuals can still contract COVID19 and transmit it?
- What population is the vaccine approved or intended for? What individuals (if any) is the vaccine not approved for or is not recommended for? Explain why/why not
- As a clinical care provider would you recommend the vaccine you researched to your patients, friends and family? Why/Why not?
- Post your responses to the above questions in the discussion thread below. I have researched the Moderna COVID-19 vaccine, marketed as Spikevax. Here's the information you requested:UPI+4American Hospital Association+4The Verge+
1. Vaccine Overview
a. Developer: The vaccine was developed by Moderna, Inc. , a biotechnology company based in Cambridge, Massachusetts.Home b. Vaccine Type:
Spikevax is an mRNA vaccine , which uses messenger RNA to instruct cells to produce a protein similar to the spike protein of the SARS-CoV-2 virus. c. Vaccine Preparation: The vaccine is prepared by synthesizing lipid nanoparticles that encapsulate the mRNA. These lipid nanoparticles protect the mRNA and facilitate its delivery into human cells upon injection. Once inside the cells, the mRNA is translated to produce the spike protein, prompting an immune response. d. Immune System Stimulation: The spike protein produced by the cells triggers the immune system to recognize it as foreign. This leads to the activation of T-cells and the production of antibodies by B-cells. These antibodies remain in the body, providing immunity against future infections with the actual virus. e. FDA Approval Status: On January 31, 2022, the U.S. Food and Drug Administration (FDA) granted full approval to Moderna's COVID-19 vaccine for individuals aged 18 and older. The vaccine is marketed under the brand name Spikevax. It had been available under Emergency Use Authorization (EUA) since December 18,
Difference Between EUA and Full Approval: o EUA allows the FDA to authorize the use of medical products during public health emergencies based on the best available evidence. o Full approval requires comprehensive data from clinical trials demonstrating the vaccine's safety, efficacy, and manufacturing quality. CNN+3UPI+3American Hospital Association+3CNN+5Verywell Health+5American Hospital Association+5CNN+1Home+
2. Vaccine Effectiveness
The Moderna vaccine does not guarantee complete immunity; vaccinated individuals can still contract and transmit COVID-19. However, it significantly reduces the severity of the disease, the risk of hospitalization, and death. Booster doses have been shown to enhance protection, especially against emerging variants. Time
3. Approved Population and Recommendations
Approved Population: The vaccine is approved for individuals aged 18 years and older.
The vaccine is manufactured using lab-engineered synthetic mRNA , which codes for the SARS- CoV-2 spike protein. The mRNA is encapsulated in lipid nanoparticles (tiny fat-like particles) to protect it and help it enter human cells. It is stored at ultra-cold temperatures to preserve the stability of the mRNA.
- Scientists create a synthetic mRNA strand in the lab that encodes instructions for making the spike protein of the coronavirus.
- The mRNA is encapsulated in tiny lipid nanoparticles to protect and help to get into the human cells.
- The vaccine is stored at ultra-low temperatures to preserve the stability of the mRNA.
d. How will the vaccine stimulate the immune system to provide immunity?
Once injected, the mRNA enters cells and instructs them to make the spike protein found on the surface of the COVID-19 virus. The immune system recognizes this foreign protein and starts producing antibodies and activating T-cells. If the person is later exposed to the real virus, their immune system can quickly recognize and fight it off.
How does the vaccine stimulate the immune system to provide immunity?
- After vaccination, the mRNA enters cells.
- The mRNA stays in the cell's cytoplasm (outside the nucleus) and provides instructions to the cell’s ribosomes to produce the spike protein.
- The immune system recognizes the spike protein as foreign and responds by producing antibodies, activating T-cells to target and destroy it (which may cause symptoms after vaccination), and creating B-cell memory to recognize the virus if exposed in the future.
e. Is the vaccine FDA approved?
Yes, the Pfizer-BioNTech COVID-19 vaccine received full FDA approval on August 23, 2021 for people aged 16 and older , under the brand name Comirnaty. It is also authorized under Emergency Use Authorization (EUA) for: o Children ages 6 months to 15 years o Some booster doses and updated formulations ✅ Difference between FDA Emergency Use Authorization (EUA) and Full Approval: EUA allows the use of unapproved medical products during public health emergencies when there is sufficient evidence that the product may be effective, and the benefits outweigh the risks.
Full FDA Approval requires comprehensive data from large-scale clinical trials proving the vaccine's safety, efficacy, and manufacturing quality. Is the vaccine FDA approved? Yes, the Pfizer-BioNTech COVID-19 vaccine received full FDA approval on August 23, 2021, for those aged 16 and older under the brand name Comirnaty. It is also authorized under Emergency Use Authorization (EUA) for:
- Children aged 6 months to 15 years
- Some booster doses and updated formulations EUA vs. Full FDA Approval:
- EUA allows the use of unapproved products during emergencies if there is enough evidence that the benefits outweigh the risks.
- Full Approval requires extensive clinical trial data proving safety, efficacy, and manufacturing quality.
2. Will the vaccine provide immunity or lessen severity?
The Pfizer vaccine does not provide sterilizing immunity (meaning it does not completely prevent infection or transmission). However, it: Greatly reduces the risk of severe illness, hospitalization, and death Lowers transmission, especially soon after vaccination Protection wanes over time , so booster shots are recommended So, vaccinated people can still get and transmit COVID-19 , but they’re much less likely to get severely sick. The Pfizer vaccine helps lessen the severity of COVID-19 by reducing the risk of severe illness, hospitalization, and death, as well as lowering the risk of transmission. Vaccinated individuals can still get infected and transmit COVID-19, but they are much less likely to experience severe illness.
3. What population is the vaccine approved or intended for?
Approved/Authorized for: 6 months and older (via EUA for younger ages)
