COVID-19 | SUBSCRIBE | FAQs

Logo Logo Logo Logo Logo
  • HOME
  • ABOUT US
    • WHO WE ARE
    • THE SAHPRA BOARD
    • EXECUTIVE MANAGEMENT
    • REGULATORY PARTNERSHIP
    • SPECIAL PROJECTS
      • BACKLOG
    • VACANCIES
  • NEWS
    • LATEST NEWS & UPDATES
    • PRESS RELEASES
    • NDOH Updates
    • PRESENTATIONS
    • SAFETY ALERTS
    • UPCOMING EVENTS
    • WORKSHOPS AND CONFERENCES
    • SAHPRA TV
  • HEALTH PRODUCTS
    • ORTHODOX MEDICINES
      • GUIDELNES
      • TEMPLATES
    • BIOLOGICAL PRODUCTS
      • GUIDELINES
    • COMPLEMENTARY MEDICINES
      • APPLICATION FORMS
      • COMMUNICATION TO INDUSTRY
      • GUIDELINES
      • TEMPLATES
    • MEDICAL DEVICES
      • APPLICATION FORMS
      • GUIDELINES
      • POSITION STATEMENTS
      • COMMUNICATION TO INDUSTRY
      • TEST KITS
      • RELATED DOCUMENTS
    • RADIATION CONTROL
      • ACTS AND REGULATIONS
      • APPLICATION AND REPORT FORMS
      • GUIDELNES AND CODES OF PRACTICE
    • UNREGISTERED PRODUCTS
      • GUIDELINES
    • VETERINARY MEDICINES
      • GUIDELNES
  • E-SERVICES
    • ACCESS TO UNREGISTERED HEALTH PODUCTS
    • ADVERSE DRUG REACTION REPORTING
    • COMPLEMENTARY MEDICINES LICENSING
    • COVI-VIG REPORTING SYSTEM
    • HEALTH PRODUCT APPLICATION STATUS CHECKER
    • PRODUCT VARIATIONS PORTAL
  • PUBLICATIONS
    • ACTS AND REGULATIONS
    • ANNUAL REPORT
    • CORPORATE IDENTITY
    • GOVERNMENT GAZETTES AND REGULATIONS
    • GUIDELINES
    • FEES
    • PRESENTATIONS
    • SAHPRA PLANNING DOCUMENTS
    • TENDERS
  • CONTACT US
    • HEAD OFFICE
    • KEY CONTACTS
    • MEDIA ENQUIRIES
    • FEEDBACK AND COMPLAINTS
  • HOME
  • ABOUT US
    • WHO WE ARE
    • THE SAHPRA BOARD
    • EXECUTIVE MANAGEMENT
    • REGULATORY PARTNERSHIP
    • SPECIAL PROJECTS
      • BACKLOG
    • VACANCIES
  • NEWS
    • LATEST NEWS & UPDATES
    • PRESS RELEASES
    • NDOH Updates
    • PRESENTATIONS
    • SAFETY ALERTS
    • UPCOMING EVENTS
    • WORKSHOPS AND CONFERENCES
    • SAHPRA TV
  • HEALTH PRODUCTS
    • ORTHODOX MEDICINES
      • GUIDELNES
      • TEMPLATES
    • BIOLOGICAL PRODUCTS
      • GUIDELINES
    • COMPLEMENTARY MEDICINES
      • APPLICATION FORMS
      • COMMUNICATION TO INDUSTRY
      • GUIDELINES
      • TEMPLATES
    • MEDICAL DEVICES
      • APPLICATION FORMS
      • GUIDELINES
      • POSITION STATEMENTS
      • COMMUNICATION TO INDUSTRY
      • TEST KITS
      • RELATED DOCUMENTS
    • RADIATION CONTROL
      • ACTS AND REGULATIONS
      • APPLICATION AND REPORT FORMS
      • GUIDELNES AND CODES OF PRACTICE
    • UNREGISTERED PRODUCTS
      • GUIDELINES
    • VETERINARY MEDICINES
      • GUIDELNES
  • E-SERVICES

    • ACCESS TO UNREGISTERED HEALTH PODUCTS
    • ADVERSE DRUG REACTION REPORTING
    • COMPLEMENTARY MEDICINES LICENSING
    • COVI-VIG REPORTING SYSTEM
    • HEALTH PRODUCT APPLICATION STATUS CHECKER
    • PRODUCT VARIATIONS PORTAL
  • PUBLICATIONS
    • ACTS AND REGULATIONS
    • ANNUAL REPORT
    • CORPORATE IDENTITY
    • GOVERNMENT GAZETTES AND REGULATIONS
    • GUIDELINES
    • FEES
    • PRESENTATIONS
    • SAHPRA PLANNING DOCUMENTS
    • TENDERS
  • CONTACT US
    • HEAD OFFICE
    • KEY CONTACTS
    • MEDIA ENQUIRIES
    • FEEDBACK AND COMPLAINTS

16 Mar SAHPRA and the Pfizer/Biontech Comirnaty Vaccine

Posted at 15:21h in News & Updates, Press Releases by Ntokozo Msiza
Share

16 March 2021

 SAHPRA has approved the Section 21 application for the Pfizer/Biontech Comirnaty Vaccine.

Download PDF

Tags:
BIONTECH, COMIRNATY, Covid-19, PFIZER, SAHPRA, vaccine


Latest News & Updates
SAHPRA Statement – Update on Sisonke Phase 3B Implementation Study
Statement by the Minister of Health, Dr Zwelini Mkhize, on the FDA’s Temporary Suspension of Johnson and Johnson vaccine rollout in the United States.
Facebook Feed
1 day ago
SAHPRA Statement – Update on Sisonke Phase 3B Implementation Study -

Latest News:

SAHPRA has engaged with the Sisonke Phase 3B Implementation Study team and Janssen Pharmaceutica. The focus of the engagement was on the safety data reported from the Sisonke study, following administration of the COVID-19 vaccine Janssen, as well as the adverse events reported in the United States of America.

Based on their review of the available data, SAHPRA has recommended that the pause in the Sisonke study be lifted, provided that specific conditions are met.

Read more:https://bit.ly/3ddMDsX
#SAHPRA #Janssen #COVID19 #vaccinecovid19
... See more

SAHPRA, together with its scientific expert committees, has recently reviewed the data from the Sisonke Phase 3b implementation study.

View on facebook
5 days ago
SAHPRA Statement – Update on Sisonke Phase 3B Implementation Study -

Press release:

SAHPRA, together with its scientific expert committees, has recently reviewed the data from the Sisonke Phase 3b implementation study. This study involves the administration of the COVID-19 vaccine Janssen, which is also referred to as the Johnson and Johnson (J&J) vaccine. Based on these data, no major safety concerns have been identified. No causal relationship between vaccination and the development of blot clots is evident at this stage.

Read more:https://bit.ly/3ddMDsX
#SAHPRA #Janssen #COVID19 #vaccinecovid19
... See more

SAHPRA, together with its scientific expert committees, has recently reviewed the data from the Sisonke Phase 3b implementation study.

View on facebook
5 days ago
National Department of Health (South Africa)

Minister of Health, Dr Zweli Mkhize today announced the temporary suspension of JnJ vaccine following FDA’s similar decision of Johnson and Johnson vaccine rollout in the United States #vaccine #VaccineRolloutSA ... See more

View on facebook
6 days ago
Regulatory Compliance and overseeing Illicit medicines and products

Watch: Ms Daphney Fafudi, Regulatory Compliance manager at SAHPRA, discusses Regulatory Compliance and overseeing Illicit medicines and products.

Ms Daphney Fafudi, Regulatory Compliance manager at SAHPRA, discusses Regulatory Compliance and overseeing Illicit medicines and products.

View on facebook
1 week ago

SAHPRA will be partnering with Bio Africa in hosting a webinar that will focus on the South African landscape and regulatory processes of IKS, Medical Cannabis and Natural Products which will help navigate South Africa’s Cannabis future.

🗓 20 April 2021
🕙 10:00 - 13:00

Registration link: https://bit.ly/3to1Nlb
... See more

View on facebook
1 week ago
SAHPRA Statement- High Court Order - Ivermectin - SAHPRA

Press release:

On 6 April 2021 the Pretoria High Court issued a court order pertaining to four cases that were brought against SAHPRA and the Minister of Health regarding access to Ivermectin for use in COVID-19. The court order was as a result of settlement agreements reached between SAHPRA, the Minister of Health and the applicants in the four cases.

Read more:https://bit.ly/31Zhwef
#SAHPRA #Ivermectin #courtorder #COVID19
... See more

9 April 2021 On 6 April 2021 the Pretoria High Court issued a court order pertaining to four cases that were brought against SAHPRA and the Minister of Health regarding access to Ivermectin for use in COVID-19. The court order was as a result of... ... See more

View on facebook
1 week ago

The Government Communication and Information System in partnership with the Department of Science and Innovation, and the national Press Club will be hosting a webinar on the role of scientific research in mitigating the COVID-19 pandemic.

🗓 9 April 2021
🕙 10:30 - 11:30
Platform: Zoom
ID (964 0705 1503) Passcode (4770401)

Zoom link: https://bit.ly/2PIzjUk
... See more

View on facebook
1 week ago
What SAHPRA does

Watch: The SAHPRA CEO discusses the mandate of SAHPRA

The SAHPRA CEO discusses the mandate of SAHPRA

View on facebook
1 week ago
Vaccines and their approval

Watch: SAHPRA CEO unpacks the process of vaccine approval

SAHPRA CEO unpacks the process of vaccine approval

View on facebook
2 weeks ago
SAHPRA registers Covid-19 Vaccine Janssen (Ad26.COV2-S [recombinant]) with conditions

Latest News:

The South African Health Products Authority (SAHPRA) registered the Covid-19 Vaccine Janssen on 31 March 2021. The registration was done in terms of Section 15(6a) of the Medicines and Related Substance Act 101 of 1965, which allows SAHPRA to register a medicine subject to certain conditions.

Read more:https://bit.ly/3dp02xh
#SAHPRA #Janssen #COVID19 #vaccinecovid19
... See more

The South African Health Products Authority (SAHPRA) registered the Covid-19 Vaccine Janssen on 31 March 2021.

View on facebook
« ‹ 1 of 4 › »
Twitter Feed

SAHPRAFollow

SAHPRA
Retweet on TwitterSAHPRA Retweeted
BioAfricaCONBIO Africa@BioAfricaCON·
8 Apr

Join our webinar: Navigating South Africa’s Cannabis Future as we focus on the South African landscape and regulatory processes which will help navigate South Africa’s Cannabis Future and unlock our potential.

Click the link below to register:

https://lnkd.in/d_m2Sj9
#Cannabis

Reply on Twitter 1380127488156651524Retweet on Twitter 13801274881566515245Like on Twitter 13801274881566515242Twitter 1380127488156651524
Load More...
CONTACT US

General Enquiries
For general, non-product specific enquiries only.
enquiries@sahpra.org.za

For Emergencies
For emergencies only.
emergency@sahpra.org.za

Quick Menu
  • Home
  • Covid-19 Updates
  • NDOH Updates
  • Safety Information
  • Payment Guideline
  • Tenders
I want to..

Apply for a vacancy

Contact SAHPRA

Know More

See Products

Read News & Updates

Newsletter Subscription

    © 2021 SAHPRA. ALL RIGHTS RESERVED

    Follow us