You are invited to attend the patient safety workshop organized by the SENSTN next Wednesday 29-30 September 2021
It is out 18 patient safety with SENSTN and 52 safety workshop since we started our first workshop during 2014
Who attend :
Please contact Mrs Azza Hasan and Rasmia Fakry at pediatrics deparment ,Mr Fakry at NICU
e mail me directly [email protected]
The program will be mailed to those who are interested to attend
The final date for registration will be 27-9-2021
please read the article and evaluate the case :
If it incident , what type ?
please answer the following :
1- what is difference between adverse event and near miss
2- Harm means:
I hope we can discuss this article value together
The Advisory Committee on Immunization Practices (ACIP) met on Friday and Saturday (Dec 11th & 12th) to discuss and develop guidance on Pfizer-BioNTech COVID-19 vaccine, the first COVID-19 vaccine to attain Emergency Use Authorization (EUA)—issued on Dec 10th.
Things continue to move rapidly but here are a few key points about this first offering:
Currently, there are three main types of COVID-19 vaccines under development. Here is a description from the CDC. A fourth type—inactivated virus—is not one of the front-runners at this point.
For neonatologists, the last point is very important. Pregnant women are recognized to be at increased risk of death or serious disease with COVID-19, but they have not been included in vaccine trials. Some women have become pregnant during their trial participation but this data is not yet released. The DART (developmental and reproductive toxicity) studies are slated to be released in late December. Pfizer stated that preliminary data showed no evidence of toxicity. Based on what we know about other coronavirus vaccine studies “the overall complete consensus was that we don’t see biological plausibility at this time for placental transfer of the mRNA and that we see that direct fetal exposure or the possibility of fetal inflammatory response is extremely unlikely,” said Eckert, professor of obstetrics and gynecology at the UW-Seattle, and the ACOG representative to ACIP. “Clearly we are waiting on the data.”
Regarding breastfeeding mothers, a recent article (https://pubmed.ncbi.nlm.nih.gov/32822495/) showed lack of transmission of SARS-CoV-2 virus in breastmilk; however other studies have demonstrated the presence of IgA against the virus. There is no data available yet regarding transmission of vaccine components.
The strong recommendation is for pregnant and nursing women to undertake shared decision-making with their providers, based on local community risk and the individual’s risk factors. This may limit liability of the manufacturer and is understandable with the paucity of data. Note that in the UK, the recommendation is for women who are pregnant (from 3 months prior to pregnancy to after delivery) to refrain from vaccination (https://www.gov.uk/government/publications/covid-19-vaccination-women-of-childbearing-age-currently-pregnant-planning-a-pregnancy-or-breastfeeding/covid-19-vaccination-a-guide-for-women-of-childbearing-age-pregnant-planning-a-pregnancy-or-breastfeeding).
For any provider engaging in shared decision-making with such patients (pregnant or lactating women, as well as immunocompromised patients, and perhaps teenagers), it is essential that good documentation is done, with clear notation of the risks and benefits discussed and the rationale for giving or withholding the vaccine.
Questions about this important perinatal population notwithstanding, I am excited about the prospect of a COVID-19 vaccine. With proper recognition of the rapidity of its development, built on the shoulders of decades of coronavirus research, it will be important to keep up with the data as it evolves. This will be especially important as different types of vaccine become available and as study populations are expanded to include broader age ranges and special groups.
Here are some references with more details on the recent vaccine guidance: