One of the agency’s highest priorities is ensuring the quality, safety and effectiveness of vaccines. This deep and abiding commitment is something that we consider essential to engendering the public’s trust in vaccines. #FDAVoices #FDAVaccineFacts fda.gov/news-events/fd…
Vaccines are one of the most significant public health interventions ever implemented. They have been largely responsible for the dramatic reduction in serious adverse consequences and death related to infectious diseases
FDA is committed to making decisions regarding the authorization or approval of #COVID19 vaccines that are guided by science and data & we are committed to expediting the development of COVID-19 vaccines, but not at the expense of sound science and decision making.
An upcoming key milestone is the meeting of our Vaccines and Related Biological Products Advisory Committee on 10/22, at which the committee will discuss publicly the general development of COVID-19 vaccines. fda.gov/news-events/pr…
While this meeting is not intended to discuss any particular vaccine candidates, the agency is also prepared to rapidly schedule additional meetings of this Committee upon submission of any applications or requests for EUAs to further ensure transparency.
We will not jeopardize the public’s trust in our science-based, independent review of these or any vaccines. There’s too much at stake.

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More from @SteveFDA

26 Aug
FDA scientific reviewers who have long experience with vaccine development are encouraged by the rapid rate of enrollment in the ongoing clinical trials for a #COVID19 vaccine.
They are looking forward to the completion of the trials so that they can evaluate data and decide whether to approve or authorize its use.
We at FDA recognize that we must build public trust so there is confidence in future decisions about vaccines for #COVID19. I am concerned when I see public surveys that many people will decline taking a vaccine.
Read 6 tweets
25 Aug
Media coverage of FDA’s decision to issue emergency authorization for convalescent plasma has questioned whether this was a politically motivated decision. The decision was made by FDA career scientists based on data submitted a few weeks ago.
They had confidence that convalescent plasma has potential to benefit many sick patients and the safety profile is well defined.
We unfortunately do not have randomized trials for convalescent plasma but must make decisions based on what we do have from the Mayo Clinic expanded access program.
Read 8 tweets
31 May
Hydroxychloroquine (HCQ) remains a safe drug for approved indications. Patients with rheumatoid arthritis and lupus should continue taking this for their conditions if prescribed by a doctor
While we at FDA wait for data from controlled trials to determine the safety and efficacy of HCQ for the treatment of #COVID19, physicians should make the decision about prescribing HCQ while assessing the risks and benefits in the context of the doctor-patient relationship.
.@US_FDA does not regulate the practice of medicine. The Agency neither endorses nor prohibits physicians from prescribing medications. Physicians prescribe drugs for patients with #COVID19 based on an assessment of the potential benefits versus risks for an individual patient.
Read 4 tweets
1 May
FDA issued an Emergency Use Authorization (EUA) to Gilead Sciences, Inc. for the investigational antiviral drug remdesivir – which has been shown to shorten recovery time in some #COVID19 clinical trial patients – to treat suspected or confirmed #COVID19. fda.gov/news-events/pr…
This EUA allows for remdesivir to be distributed in the U.S. & administered intravenously in adults & children with severe #COVID19 disease, defined as low blood oxygen levels or needing oxygen therapy or more intensive breathing support, like a ventilator.
Issuing an EUA is different than FDA approval. In determining whether to issue an EUA, FDA evaluates the available scientific evidence very quickly and carefully balances any known and potential benefits and/or risks of these products to the public.
Read 6 tweets
24 Apr
While clinical trials are ongoing to determine the safety and effectiveness of hydroxychloroquine and chloroquine for #COVID19, there are known side effects of these medications that should be considered. fda.gov/news-events/pr…
FDA issued a Drug Safety Communication regarding known side effects of hydroxychloroquine & chloroquine, including potentially life-threatening heart rhythm problems, reported with their use for treatment or prevention of #COVID19, for which they are not FDA-approved.
We understand that health care professionals are looking for every possible treatment option for their patients and we want to ensure we’re providing them with the appropriate information needed to make the best medical decisions.
Read 7 tweets
4 Apr
Based on prior experience with respiratory viruses & on data from China, convalescent plasma – the plasma from the blood of recovered #COVID19 patients – may potentially lessen severity or shorten the illness caused by #COVID19. fda.gov/news-events/pr…
FDA is facilitating access to convalescent plasma to treat #COVID19 using multiple pathways. Our initial effort focused on emergency investigational new drug applications (eINDs), & we provided info to help health care providers submit applications to treat individual patients.
FDA is also facilitating the conduct of well-controlled clinical trials at academic institutions across the U.S. to evaluate the safety & efficacy of convalescent plasma for use in #COVID19 patients.
Read 7 tweets

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