Vaccine Development and Approval
Vaccine FAQs Index>>
What is Operation Warp Speed (OWS)?
Updated 12/4/20
Operation Warp Speed (OWS) is an initiative launched by the U.S. government to expedite the development and delivery COVID-19 vaccines, with the goal of delivering 300 million doses of safe and effective vaccines to the American people as part of a broader strategy to accelerate the development of COVID-19 vaccines, therapeutics, and diagnostics. OWS aims to make the initial doses of safe and effective vaccines available by January 2021.
In order to reach this goal, OWS is investing in the development of these treatments and coordinating efforts between government agencies and private companies. OWS is accelerating the vaccine development process while maintaining standards for safety and efficacy and will reduce the timeline from what typically takes 73 months down to just 14 months.
How do I know the vaccines being developed under OWS are safe?
Updated 12/4/20
To meet the compressed timeline for vaccine development, OWS is not sacrificing the evaluation of safety of these vaccines by eliminating steps – instead, steps are occurring simultaneously. OWS has aligned protocols for the demonstration of safety and efficacy, allowing clinical trials to proceed at a faster pace. OWS has also invested in starting manufacturing of the most promising vaccine candidates at industrial scale prior to demonstration of vaccine efficacy and safety. This means the government is taking a financial risk in started manufacturing ahead of approval but does not increase product risk. Vaccine safety standards are not being compromised in efforts to accelerate development and distribution.
How do COVID-19 mRNA vaccines work?
Updated 12/18/20
The messenger RNA (or mRNA) vaccines for COVID-19 contain a code that instructs our cells to make what is called “spike protein” that triggers an immune response in our bodies. These vaccines are protected by fat bubbles (called lipid nanoparticles), which act as shuttles to carry the mRNA to the cells. The mRNA essentially teaches our cells to produce harmless spike proteins, and, in response, the cells begin building an immune defense by making antibodies. After that process is complete, our immune system knows how to protect against future infection without ever having to introduce the live virus into the body through the vaccine.
mRNA vaccines will never affect or interact with your DNA or alter your genetic code in any way. In fact, once the cell has finished using the instructions from the mRNA vaccine, the cells break it down and eliminate the mRNA from our bodies entirely.
Are COVID-19 mRNA vaccines safe?
Updated 12/7/20
Yes, all COVID-19 mRNA vaccines are being held to the same rigorous safety and efficacy standards as all other vaccines. The FDA will only approve COVID-19 vaccines for use if they meet the necessary standards.
Can I get sick from the COVID-19 vaccines?
Updated 3/4/21
No, the COVID-19 vaccines do not contain the virus that causes COVID-19 and will not make you sick. All of the COVID-19 vaccines are inactivated vaccines.
Why did the Pfizer vaccine get approved for use in the U.K. before the U.S.?
Updated 12/18/20
The Pfizer vaccine was approved in the U.K. ahead of the U.S. because of a difference in how vaccines are authorized in each country. In the U.S., the FDA conducts a thorough analysis of all raw data from clinical trials to validate the results, whereas most other countries do not conduct a regulatory review of raw data. Instead, the U.K. and other countries rely on pharmaceutical manufacturers’ data, which speeds up the review and approval process. Regulators in the U.K. study the reports provided by manufacturers and make decisions based on these analyses unless there are anomalies that require further examination.
What vaccines will UMMS be administering?
Updated 03/11/21
UMMS is administering all COVID-19 vaccines that are available for use under emergency use authorization (EUA) from the FDA and have been endorsed by the CDC with recommendations for use. The FDA granted EUA for the Pfizer vaccine on December 11, 2020, the Moderna vaccine on December 18, 2020, and the Johnson & Johnson vaccine on February 27, 2021.
We are awaiting status updates regarding the other vaccine candidates currently in phase III clinical trials and will make decisions once those trials have completed and the data have been reviewed.
Can you explain why the COVID-19 vaccines are authorized for use but are still “unapproved”?
Updated 12/21/20
An emergency use authorization (EUA) is a mechanism to facilitate the use of medical products, including testing platforms, treatments and vaccines, during public health emergencies, such as the current COVID-19 pandemic. It is not uncommon for the FDA to use EUAs – in fact, the FDA employed the use of EUAs to respond to previous public health emergencies including Zika virus, Ebola virus, MERS, H1N1 and Anthrax.
During the course of the current pandemic there have been numerous EUAs issued, including for the tests we use to diagnose COVID-19. Under an EUA, FDA may allow the use of unapproved medical products to diagnose, treat, or prevent serious or life-threatening diseases or conditions. However, each product that is granted an EUA must still make its way through the full FDA approval process to receive official FDA approval.
As the Pfizer, Moderna and Johnson & Johnson COVID-19 vaccines are still working their way through this process, they are technically “unapproved” in the context of full FDA approval. They are, however, authorized for immediate use under the guidelines of the EUA.
How do COVID-19 viral vector vaccines work?
Updated 3/4/21
Viral vector vaccines use a modified version of an inactive virus (not the virus that causes COVID-19, but a different, harmless virus) to make what is called “spike protein.” This triggers an immune response in our bodies, causing our immune system to produce antibodies to fight off what it thinks is an infection. Afterwards, our bodies have learned how to protect against future infection from the virus that causes COVID-19, without ever having to get sick with COVID-19. Viral vector vaccines do not affect or interact with your DNA in any way.
Vaccine FAQs Index>>