V114 is an investigational vaccine currently being evaluated for its ability to provide protection against pneumococcal disease caused by serotypes contained in the vaccine.
For further information on clinical trials, please refer to:
*In the pipeline chart included in the Company’s Form 10-Q for the quarterly period ended June 30, 2022, the Company inadvertently listed MK-1200 in Phase 2. MK-1200 is currently in Phase 1.
What do the phases of clinical trials mean?
Phase 1
Phase 1 clinical trials test the medicine or vaccine in a small group of 20 to 100 volunteers who are usually healthy, but not always. The trial often takes place in a hospital. The goals are to determine:
If the medicine or vaccine is safe
If there are any side effects
How the medicine is broken down by and discharged from the body
How much medicine is needed and how often
For a vaccine, researchers see if it causes the desired response from the body’s immune system
Phase 1 trials an take from six months to one year to complete.
Phase 2
Phase 2 clinical trials test the vaccine or medicine in approximately 100 to 500 volunteers. In the case of medicines, volunteers usually have the disease or condition the investigational medicine is designed to treat. In vaccine studies, the volunteers are usually healthy. The goals of this phase are to determine:
How well the medicine or vaccine works
If the medicine or vaccine is safe
If there are any side effects
How much of the medicine or vaccine is needed and how often
Phase 2 trials can take from six months to one year or more to complete.
Phase 3
Phase 3 clinical trials can test the medicine or vaccine in 1,000 to 5,000 patient volunteers. For medicines, volunteers have the disease or condition the medicine is designed to treat. In vaccine studies, the volunteers may be healthy or have diseases or conditions. Phase 3 trials take place in hospitals, clinics or physician offices. Researchers closely monitor patients at regular intervals to:
Confirm that the medication or vaccine is effective
Identify and monitor side effects
Compare the medicine or vaccine to commonly used treatments
Phase 3 trials can take from one to four years to complete, depending on the disease, length of study and number of volunteers.
Under review
The application has been submitted to the regulatory authorities for review.
No Duty to Update
The information contained in this chart was current as of August 1, 2022. While this pipeline chart remains on the company’s website the company assumes no duty to update the information to reflect subsequent developments. Consequently, the company will not update the information contained in the presentation and investors should not rely upon the information as current or accurate after August 1, 2022.
The chart reflects the company research pipeline as of August 1, 2022.
Candidates shown in Phase 3 include specific products. Candidates shown in Phase 2 include the most advanced compound with a specific mechanism in a given therapeutic area. Phase 1 candidates are not shown.
Forward-looking statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the recent global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2021 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
No Duty to Update
The information contained in this website was current as of the date presented. The company assumes no duty to update the information to reflect subsequent developments. Consequently, the company will not update the information contained in the website and investors should not rely upon the information as current or accurate after the presentation date.
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