完整標題：Coronavirus (COVID-19) Update: July 13, 2021
發稿單位：美國fda
發稿時間：2021/7/13 (台灣時間7/14)
原文連結：https://bit.ly/3hAeGVG
For Immediate Release:July 13, 2021
The U.S. Food and Drug Administration today announced the following actions
taken in its ongoing response effort to the COVID-19 pandemic:
Today, the FDA is announcing revisions to the vaccine recipient and vaccinat
ion provider fact sheets for the Johnson & Johnson (Janssen) COVID-19 Vaccin
e to include information pertaining to an observed increased risk of Guillai
n-Barré Syndrome (GBS) following vaccination. GBS is a neurological disorder
in which the body’s immune system damages nerve cells, causing muscle weak
ness, or in the most severe cases, paralysis. Based on an analysis of Vaccin
e Adverse Event Reporting (VAERS) data, there have been 100 preliminary repo
rts of GBS following vaccination with the Janssen vaccine after approximatel
y 12.5 million doses administered. Of these reports, 95 of them were serious
and required hospitalization. There was one reported death. Each year in th
e United States, an estimated 3,000 to 6,000 people develop GBS. Most people
fully recover from the disorder. GBS has also been observed at an increased
rate associated with certain vaccines, including certain seasonal influenza
vaccines and a vaccine to prevent shingles. 辠lthough the available evidenc
e suggests an association between the Janssen vaccine and increased risk of
GBS, it is insufficient to establish a causal relationship. No similar signa
l has been identified with the Moderna and Pfizer-BioNTech COVID-19 vaccines
. FDA continues to work with its partner in vaccine safety surveillance, the
CDC, to monitor reports of GBS following vaccination with the Janssen COVID
-19 Vaccine. Importantly, the FDA has evaluated the available information fo
r the Janssen COVID-19 Vaccine and continues to find the known and potential
benefits clearly outweigh the known and potential risks.
The Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administeri
ng Vaccine (Vaccination Providers) has been revised to include a warning abo
ut GBS and the Fact Sheet for Recipients and Caregivers has been revised to
include information about GBS. The warning in the Fact Sheet for Healthcare
Providers Administering Vaccine notes that reports of adverse events suggest
an increased risk of GBS. Additionally, the Fact Sheet for Recipients and C
aregivers notes that vaccine recipients should seek medical attention right
away if they develop any of the following symptoms after receiving the Janss
en COVID-19 Vaccine: weakness or tingling sensations, especially in the legs
or arms, that’s worsening and spreading to other parts of the body; diffic
ulty walking; difficulty with facial movements, including speaking, chewing
or swallowing; double vision or inability to move eyes; or difficulty with b
ladder control or bowel function.
Today the agency authorized the use, under the emergency use authorization (
EUA) for the Janssen COVID-19 vaccine, of an additional batch of vaccine dru
g substance manufactured at the Emergent facility. To date, a total of five
batches of Janssen drug substance that were manufactured at the Emergent fac
ility have been authorized. The FDA conducted a thorough review of facility
records and the results of quality testing performed by the manufacturer. Ba
sed on this review and considering the current COVID-19 public health emerge
ncy, the FDA has concluded that these batches are suitable for use. While th
e FDA is not yet ready to include the Emergent BioSolutions plant in the Jan
ssen EUA as an authorized manufacturing facility, the agency continues to wo
rk through issues there with Janssen and Emergent BioSolutions management.
The FDA Center for Drug Evaluation and Research has published aFrom Our Per
spectiveon the FDA’s Clinical Methodologies Group’s recent U.S. Departmen
t of Health and Human Services (HHS) award, which will fund expansion of the
CURE ID platformExternal Link Disclaimer. The platform will allow automated
anonymized data collection from electronic health records and clinical dise
ase registries for COVID-19 and other difficult-to-treat infectious diseases
. This work may facilitate the clinical, research, and regulatory communitie
s to identify signals of potentially safe and effective COVID-19 therapies t
hat may also be candidates for additional study in randomized clinical trial
s. In the future, CURE ID’s expansion will also include a platform for pati
ents with long COVID to upload information on their treatments, in addition
to the treatment outcomes they consider most important.
As part of the FDA’s effort to protect consumers, the agency issued a warni
ng letter to one network operating two websites,www.premierdream.comandww
w.eirmed360.com, for marketing unapproved drugs for multiple diseases, inclu
ding COVID-19. Drugs that have circumvented regulatory safeguards may be con
taminated, counterfeit, contain varying amounts of active ingredients or con
tain different ingredients altogether. Consumers can visitBeSafeRxto learn
about how to safely buy medicine online. Consumers concerned about COVID-19
should consult with their health care provider.
Testing updates:
As of today, 396 tests and sample collection devices are authorized by the F
DA under emergency use authorizations (EUAs). These include 282 molecular te
sts and sample collection devices, 85 antibody and other immune response tes
ts and 29 antigen tests. There are 52 molecular authorizations and one antib
ody authorization that can be used with home-collected samples. There is one
molecular prescription at-home test, three antigen prescription at-home tes
ts, five antigen over-the-counter (OTC) at-home tests and two molecular OTC
at-home tests.
The FDA has authorized 11 antigen tests and seven molecular tests for serial
screening programs. The FDA has also authorized 572 revisions to EUA author
izations.
Related Information
COVID-19 Vaccines
Coronavirus Disease 2019 (COVID-19)
###
The FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and securi
ty of human and veterinary drugs, vaccines and other biological products for
human use, and medical devices. The agency also is responsible for the safe
ty and security of our nation’s food supply, cosmetics, dietary supplements
, products that give off electronic radiation, and for regulating tobacco pr
oducts.
簡單來說就是有個疑似12.5萬分之一的副作用
好發於老年男性
另外兩支mrna疫苗沒有觀察到類似現象
嬌生則採用與az類似的病毒載體疫苗技術