These guidelines have been developed for scientific purpose with the main aim to guide the regulatory authority for evaluating probiotic products in our country.
The guidelines reiterate that the general principles of ethics for biomedical research involving human participants shall also be applicable. In addition, the guidelines specify unique provisions for stem cells, because of their inherent property for unlimited proliferation, differentiation to cells... of the germ layers, oncogenic potential, unrecognised toxicities and possible involvement in pre-implantation stages of human development. The guideline therefore focuses on: 1. Monitoring mechanism and regulatory pathway for basic, clinical research and product development based on categories of research and level of manipulation. 2. Procurement of gametes, embryos and somatic cells for derivation and propagation of any stem cell lines, their banking and distribution. 3. Other important areas like international collaboration, exchange of cell/lines and education for stakeholders and advertisement.
more
Original Research
African Journal of Primary Health Care & Family Medicine
ISSN: (Online) 2071-2936, (Print) 2071-2928
Open Access
Early data from US biotech Moderna has revealed that its Covid-19 vaccine candidate is 94.5 per cent effective, raising hopes that a range of immunisations will be available to help end the pandemic.
The interim analysis of the vaccine, currently known as mRNA-1273, comes after 95 trial particip...ants contracted Covid-19, including just five who were given the coronavirus jab.
more
COVAXINTM, India's indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) h...igh containment facility.
The vaccine received DCGI approval for Phase I & II Human Clinical Trials and the trials commenced across India from July, 2020.
After successful completion of the interim analysis from the Phase 1 & 2 clinical trials of COVAXINTM, Bharat Biotech received DCGI approval for Phase 3 clinical trials in 26,000 participants in over 25 centres across India.
more
Information about vaccine administration
Interim guidance, 26 October 2021
This interim guidance has been developed on the basis of the advice issued by the Strategic Advisory Group of Experts (SAGE) on Immunization at its meeting on 5 October 2021.
SAGE said moderately and severely immunocompromised persons should be offered an addition...al dose of all WHO approved vaccines “since these individuals are less likely to respond adequately to vaccination following a standard primary vaccine series and are at high risk of severe COVID-19 disease.”
People aged 60 and older who received the Sinovac and Sinopharm vaccines should get a third dose too, the experts added, though use of other vaccines may also be considered depending on supply and access.
“When implementing this recommendation, countries should initially aim at maximizing 2-dose coverage in that population, and thereafter administer the third dose, starting in the oldest age groups”, they said.
SAGE has also reviewed a vaccine developed by Indian company Bharat Biotech and will issue a policy recommendation after WHO greenlights it for emergency use.
more
Comirnaty® 10 μg und 30 μg von BioNTech / Pfizer und Spikevax® von Moderna
Stand 21. Dezember 2021
Comirnaty® 10 μg und 30 μg von BioNTech / Pfizer und Spikevax® von Moderna
Seit August 2021 empfiehlt die Ständige Impfkommission (STIKO) allen Kindern und Jugendlichen ab 12 Jahren die Corona-Schutzimpfung mit Comirnaty® von BioNTech/Pfizer. Seit Mitte Dezember können auch Kinder zwischen 5 und 11 Jahren mit dem darauf angepassten Impfstoff von BioNTech/Pfizer geimpft ...werden. Hier finden Sie alles zur Zulassung und der STIKO-Empfehlung sowie kindgerechte Dokumente und Hintergrundinformationen für den Alltag mit Kindern in der Pandemie.
more
PHARMA’S RESPONSE TO THE COVID-19 VACCINES CRISIS. Update Feb., 14, 2022. In September 2021, Amnesty International published A Double Dose of Inequality, which assessed the extent to which the pharmaceutical industry was restricting access to Covid-19 vaccines. This report updates that assessment ...of five leading vaccine manufacturers, AstraZeneca plc, BioNTech SE, Johnson & Johnson, Moderna Inc., and Pfizer Inc. It also includes for the first time an assessment of the two largest Chinese vaccine producers, China National Pharmaceutical Group Co., Ltd. (Sinopharm) and Sinovac Biotech Ltd. (Sinovac).
more
22 Sept. 2021
The rapid development of effective Covid-19 vaccines in 2020 gave hope to the world in the darkest days of the deadly pandemic. However, the vaccine roll-out has been massively skewed towards wealthy nations. While rich states have hoarded vaccines, companies have also played a decisi...ve role in restricting fair access to a life-saving health product. This report focuses on six leading vaccine developers, AstraZeneca, BioNTech, Johnson & Johnson, Moderna, Novavax and Pfizer, assessing each company’s human rights policy, pricing structure, records on intellectual property, knowledge and technology sharing, allocation of available vaccine doses and transparency.
Available in Arabic, English, French, German and Spanish
more
(Comirnaty® 10 мкг або 30 мкг виробництва BioNTech/Pfizer та Spikevax® виробництва Moderna);
Anamnese zur Schutzimpfung gegen COVID-19 (Corona Virus Disease 2019) (Grundimmunisierung und Auffrischimpfungen)
– mit mRNA-Impfstoffen –
(Comirnaty® 10 μg bzw. ...30 μg von BioNTech/Pfizer und Spikevax® von Moderna)
more
– (Comirnaty® 10 мкг або 30 мкг виробництва BioNTech/Pfizer та
AUFKLÄRUNGSMERKBLATT
Zur Schutzimpfung gegen COVID-19 (Corona Virus Disease 2019) (Grundimmunisierung und Auffrischimpfungen)
– mit mRNA-Impfstoffen –
(Comirnaty® 10 μg bzw. 30 μg von BioNTech/Pfizer... und Spikevax® von Moderna)
more
– з вакциною на білковій основі
(Nuvaxovid® виробництва Novavax)
Станом на: 15 лютого 2022 р. (даний інформаційний лист постійно оновлюється)
AUFKLÄRUNGSMERKBLATT
Zur Schutzimpfung gegen COVID-19 (Cor...ona Virus Disease 2019) (Grundimmunisierung )
– mit proteinbasiertem Impfstoff –
(Nuvaxovid® von Novavax)
Stand: 15. Februar 2022 (dieser Aufklärungsbogen wird laufend aktualisiert)
(Comirnaty® 10 μg bzw. 30 μg von BioNTech/Pfizer und Spikevax® von Moderna)
more
En Paraguay, la vacunación contra COVID-19 inició el 22 de febrero de 2021. Se han autorizado un total de siete vacunas: Bharat-Covaxin, Moderna, Pfizer-BioNTech, AstraZeneca, Sinopharm, Sputnik V- Gamaleya y CoronaVac-Sinovac. Los grupos prioritarios de vacunación están definidos según el Plan... Nacional de Vacunación contra COVID-19 en Paraguay
more
La dosis de refuerzo está indicada una vez transcurridos los 4 meses (120 días) de la última dosis del esquema inicial y será con vacuna de plataforma ARNm: Pfizer-BioNTech pediátrica a partir de los 5 años o Moderna para uso pediátrico a partir de los 6 años.
La evidencia disponible a nivel internacional sobre el uso de un segundo refuerzo muestra una mayor duración de la respuesta inmune y una disminución de la internación y la mortalidad por COVID 19 en la población de adultos mayores y huéspedes inmunocomprometidos. Por otra parte, el personal de... salud se beneficiaría considerando el mayor riesgo de exposición y la caída de la respuesta inmune con el tiempo. En base a lo señalado previamente se recomienda incorporar y
priorizar un segundo refuerzo al esquema de vacunación contra la COVID-19 del:
- Personal de salud independientemente de la edad
- Personas de 50 años o mayores
- Personas de 12 años o más con inmunocompromiso
A la vez, se progresará de manera escalonada y simultánea con la vacunación de segundo refuerzo del:
- Personal estratégico
- Personas de 18 a 49 años con factores de riesgo
Continuando en la estrategia de segundo refuerzo todas las personas a partir de los 18 años. Las personas gestantes con indicación de segundo refuerzo, se recomienda vacunas de plataforma de ARNm (Pfizer-BioNTech o Moderna)
more
With the growing prevalence of type 2 diabetes, particularly in emerging countries, its management in the context of available resources should be considered. International guidelines, while comprehensive and scientifically valid, may not be appropriate for regions such as Asia, Latin America or Afr...ica, where epidemiology, patient phenotypes, cultural conditions and socioeconomic status are different from America and Europe. Although glycaemic control and reduction of micro- and macrovascular outcomes remain essential aspects of treatment, access and cost are major limiting factors; therefore, a pragmatic approach is required in restricted-resource settings. Newer agents, such as sodium–glucose cotransporter 2 inhibitors and glucagon-like peptide 1 receptor agonists in particular, are relatively expensive, with limited availability despite potentially being valuable for patients with insulin resistance and cardiovascular complications. This review makes a case for the role of more accessible second-line treatments with long-established efficacy and affordability, such as sulfonylureas, in the management of type 2 diabetes, particularly in developing or restricted-resource countries.
more