European agency clears Moderna vaccine for children 12-17
The European Medicines Agency has recommended clearing Moderna’s COVID-19 vaccine for children ages 12 to 17, the first time the shot has been authorized for people under 18 (Source: ABC News: Health)
Source: ABC News: Health - July 23, 2021 Category: Consumer Health News Tags: Health Source Type: news

The European Medicines Agency recommends approving Moderna’s COVID-19 vaccine for children aged 12 to 17
The European Medicines Agency recommends approving Moderna’s COVID-19 vaccine for children aged 12 to 17 (Source: ABC News: Health)
Source: ABC News: Health - July 23, 2021 Category: Consumer Health News Tags: Health Source Type: news

Johnson & Johnson Reports Q2 2021 Results
New Brunswick, N.J. (July 21, 2021) – Johnson & Johnson (NYSE: JNJ) today announced results for second-quarter. “Our second-quarter results showcase Johnson & Johnson’s diversified portfolio, driven by strong sales and earnings growth across our Medical Device, Consumer Health and Pharmaceutical businesses,” said Alex Gorsky, Chairman and Chief Executive Officer. “I’m so proud of our 136,000 colleagues who remain focused on delivering our medicines and products to patients and consumers around the world, in addition to advancing our pipeline with new product launches and regulato...
Source: Johnson and Johnson - July 21, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

European Medicines Agency grants Orphan Drug Designation to Zydus Cadila's Saroglitazar Mg
Orphan Drug status in Europe is given to medicines with the potential to be safe and effective treatments for rare, life-threatening, or chronically debilitating conditions affecting no more than 5 people in 10,000 people. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 21, 2021 Category: Pharmaceuticals Source Type: news

EU likely to decide on Moderna COVID shot for kids next week
A top official at the European Medicines Agency says a decision on whether to recommend that Moderna’s COVID-19 vaccine be authorized for children is expected late next week (Source: ABC News: Health)
Source: ABC News: Health - July 15, 2021 Category: Consumer Health News Tags: Health Source Type: news

Johnson & Johnson Statement on COVID-19 Vaccine (7/12)
NEW BRUNSWICK, N.J., July 12, 2021 – The safety and well-being of the people who use our products is our number one priority. Rare cases of the neurological disorder, Guillain-Barré syndrome have been reported following vaccination with the Janssen COVID-19 vaccine. Most occurred within 42 days after vaccination. While the chance of having this occur is very low, Johnson & Johnson has updated its COVID-19 Vaccine Factsheet to include important information about these rare cases and on the signs and symptoms of Guillain-Barré syndrome. Updates with this new information will be implemented in other regions...
Source: Johnson and Johnson - July 12, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Africa: Discriminatory EU Vaccines Passport Mark of Duplicity
[Capital FM] A plan by the European Union not to recognize Covid-19 vaccines manufactured outside the block could set back global efforts to contain the pandemic. The intended vaccines passport by the EU risks leaving out travelers from developing countries who have largely received vaccines made outside the EU and the US. What is more appalling is that some EU member states have been actively donating vaccines not recognized by the European Medicines Agency to poor countries such as the Covishield. (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - July 5, 2021 Category: African Health Source Type: news

Delta Variant Not Driving Hospitalization Surge in England, Data Shows
Although the number of coronavirus infections has risen sharply in recent weeks, hospitalization rates remain low. (Source: NYT Health)
Source: NYT Health - July 1, 2021 Category: Consumer Health News Authors: Emily Anthes Tags: Disease Rates Vaccination and Immunization Coronavirus (2019-nCoV) England European Medicines Agency Source Type: news

Serum Institute confident of European drug regulator nod for Covishield in a month
Poonawalla said SII has applied to the European Medicines Agency (EMA) through AstraZeneca. "The process has to take its time. An approval process even with UK MHRA, WHO took its time and we have applied to the EMA," he said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 1, 2021 Category: Pharmaceuticals Source Type: news

Covid-19: Double doses of vaccine seems to curb Delta variant, says European Medicines Agency
(Source: The Economic Times)
Source: The Economic Times - July 1, 2021 Category: Consumer Health News Source Type: news

EU-approved COVID-19 vaccines protect against Delta variant, says official
"There have been a number of variants over the last months and we expect more," said Marco Cavaleri, European Medicines Agency's (EMA) head of vaccine strategy, during a press briefing. (Source: The Economic Times)
Source: The Economic Times - July 1, 2021 Category: Consumer Health News Source Type: news

EU Green Light for Roxadustat in Anemia of Kidney Disease EU Green Light for Roxadustat in Anemia of Kidney Disease
European Medicines Agency committee issues a positive opinion for roxadustat, which would be the first orally administered treatment for adults with CKD-associated anemia.International Approvals (Source: Medscape Transplantation Headlines)
Source: Medscape Transplantation Headlines - June 29, 2021 Category: Transplant Surgery Tags: Nephrology News Alert Source Type: news

Serum Institute asks govt to take up inclusion of Covishield in EU vaccination passport
Only four vaccines -- Comirnaty of Pfizer/BioNTech, Moderna, Vaxzervria by AstraZeneca-Oxford and, Johnson& Johnson's Janssen -- have been approved by the European Medicines Agency (EMA). Only those inoculated with these vaccines will be given vaccination passports and allowed to travel within the EU during the pandemic. (Source: The Economic Times)
Source: The Economic Times - June 28, 2021 Category: Consumer Health News Source Type: news

Moderna seeks approval for giving its Covid vaccine to children in Europe
Covid-19 vaccine maker Moderna has asked the European Medicines Agency for permission to give its jab to children aged between 12 and 17. (Source: the Mail online | Health)
Source: the Mail online | Health - June 7, 2021 Category: Consumer Health News Source Type: news

The Latest: Moderna seeks to use vaccine for adolescents
Moderna Inc. has filed a request with the European Medicines Agency for its COVID-19 vaccine to be granted authorization for use in adolescents (Source: ABC News: Health)
Source: ABC News: Health - June 7, 2021 Category: Consumer Health News Tags: Health Source Type: news

France planning to inject 12-year-old children with spike protein bioweapons
(Natural News) The President of France, Emmanuel Macron, recently announced the government’s plan to prey on psychologically vulnerable parents and vaccinate as many children as possible. Children as young as 12 years of age will be pressured to inoculate with experimental spike proteins from the Pfizer-BioNTech vaccine series. The European Medicines Agency recently approved the... (Source: NaturalNews.com)
Source: NaturalNews.com - June 4, 2021 Category: Consumer Health News Source Type: news

Pfizer and BioNTech receive first authorization in European Union for COVID-19 vaccine in adolescents
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that the Conditional Marketing Authorization (CMA) for COMIRNATY® in the European Union (EU) has been expanded to include individuals 12 to 15 years of age. This follows the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group. (Source: World Pharma News)
Source: World Pharma News - June 2, 2021 Category: Pharmaceuticals Tags: Featured Business Business and Industry Source Type: news

Janssen Highlights Commitment to Advancing Transformative Innovations in Oncology with Scientific Updates from Deep, Diverse Pipeline and Portfolio at ASCO and EHA Virtual Scientific Programs
June 1, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that more than 30 company-sponsored studies, including six oral presentations, will be featured during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, June 4-8. Janssen presentations will include new data and updates for both approved and investigational therapeutics that are being studied for the treatment of various solid tumors and blood cancers. Immediately following ASCO, additional data will be featured during the European Hematology Association (EHA) Virtual Congress, June 9-17. A ...
Source: Johnson and Johnson - June 1, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma
U.S. Milestone Follows European Medicines Agency PRIME Designation for this BCMA Bispecific Antibody for the Treatment of Relapsed or Refractory Multiple Myeloma RARITAN, N.J., June 1, 2021 -- (Healthcare Sales & Marketing Network) -- The Janssen Pharm... Biopharmaceuticals, Oncology, FDA Janssen Pharmaceutical, Johnson & Johnson, teclistamab, Multiple Myeloma (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - June 1, 2021 Category: Pharmaceuticals Source Type: news

Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma
June 1, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for teclistamab in the treatment of relapsed or refractory multiple myeloma. This distinction for teclistamab, an off-the-shelf, T-cell redirecting, bispecific antibody targeting both B-cell maturation antigen (BCMA) and CD3 receptors, follows a PRIME (PRIority MEdicines) designation from the European Medicines Agency (EMA) received earlier this year. Today’s BTD marks the 11th received by Janssen’s ...
Source: Johnson and Johnson - June 1, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Reports New Data for BCMA CAR-T, Cilta-Cel, Showing Deep and Durable Responses in Patients with Relapsed or Refractory Multiple Myeloma
June 1, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data for ciltacabtagene autoleucel (cilta-cel), an investigational B-cell maturation antigen (BCMA)-directed CAR-T therapy, demonstrated sustained efficacy and durable responses in heavily pretreated patients with relapsed/refractory multiple myeloma (RRMM). Updated results from the Phase 1b/2 CARTITUDE-1 study (n=97) with a longer-term follow-up at a median of 18 months showed an overall response rate (ORR) of 98 percent, with 80 percent of patients achieving a stringent complete response (sCR), highlight...
Source: Johnson and Johnson - June 1, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

European regulator recommends Pfizer shot for children 12-15
The European Medicines Agency has recommended that the use of the coronavirus vaccine made by Pfizer and BioNTech be expanded to children ages 12 to 15 (Source: ABC News: Health)
Source: ABC News: Health - May 28, 2021 Category: Consumer Health News Tags: Health Source Type: news

European Medicines Agency approves Pfizer jab for 12 to 15-year-olds
Decision paves way for EU countries to start vaccinating school-age children (Source: FT.com - Drugs and Healthcare)
Source: FT.com - Drugs and Healthcare - May 28, 2021 Category: Pharmaceuticals Source Type: news

European Medicines Agency issues advice on sotrovimab (VIR-7831) for COVID-19, EMA
Following a review, the agency has concluded that sotrovimab, an investigation monoclonal antibody, can be used to treat confirmed COVID-19 in adults and adolescents (> 40 kg) who do not require supplemental oxygen therapy and are at risk of progressing to severe COVID-19. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - May 25, 2021 Category: Consumer Health News Source Type: news

European Commission approves PONVORYTM (ponesimod), a Once Daily, Oral Therapy for the Treatment of Adults with Relapsing Forms of Multiple Sclerosis with Active Disease Defined by Clinical or Imaging Features
BEERSE, BELGIUM, May 24, 2021 – Janssen, the Pharmaceutical Companies of Johnson & Johnson, announced today that the European Commission (EC) has approved PONVORY (ponesimod) for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features.[4] “Relapsing multiple sclerosis is an unpredictable and complex disease that can present very differently from individual to individual, placing a heavy burden on the patient and their loved ones,” said Professor Gavin Giovannoni, MBBCh, PhD, FCP (Neurol., SA), FRCP, FRCPath, Professor of Neuro...
Source: Johnson and Johnson - May 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Russia ’s Sputnik Diplomacy
This article was originally published in the community blog Persuasion.   Follow @IPSNewsUNBureau !function(d,s,id){var js,fjs=d.getElementsByTagName(s)[0],p=/^http:/.test(d.location)?'http':'https';if(!d.getElementById(id)){js=d.createElement(s);js.id=id;js.src=p+'://platform.twitter.com/widgets.js';fjs.parentNode.insertBefore(js,fjs);}}(document, 'script', 'twitter-wjs');   Excerpt: The writer is a journalist and managing editor of Armando.info, an investigative journalism site. (Source: IPS Inter Press Service - Health)
Source: IPS Inter Press Service - Health - May 13, 2021 Category: International Medicine & Public Health Authors: Valentina Lares Tags: Development & Aid Featured Global Headlines Health Humanitarian Emergencies IPS UN: Inside the Glasshouse Poverty & SDGs TerraViva United Nations Source Type: news

AstraZeneca vaccine side effects: Blood clot risk 'higher than estimated' - new study
THERE is a broad consensus within the scientific community that the risks posed by catching COVID-19 far outweigh the risks posed by getting the AstraZeneca vaccine. Nonetheless, a new research suggests the risk of blood clots is slightly "higher than estimated" by the European Medicines Agency . (Source: Daily Express - Health)
Source: Daily Express - Health - May 10, 2021 Category: Consumer Health News Source Type: news

EMA starts rolling review of sotrovimab (VIR-7831) for COVID-19, European Medicines Agency
The decision to start the rolling review was based on preliminary results from an ongoing study evaluating it in the treatment of non-hospitalised patients with Covid-19. The review will continue until enough evidence is available to support a marketing authorisation application. 7 May. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - May 10, 2021 Category: Consumer Health News Source Type: news

AstraZeneca vaccine reactions: Blood clots still 'very rare' – other side effects to note
THE ASTRAZENECA Covid vaccine is now under investigation from the European Medicines Agency . This follows recipients of the jab developing Guillain-Barre syndrome - another side effect connected to the vaccine. (Source: Daily Express - Health)
Source: Daily Express - Health - May 7, 2021 Category: Consumer Health News Source Type: news

EMA to Quickly Review Lilly, Incyte Arthritis Drug for COVID Use EMA to Quickly Review Lilly, Incyte Arthritis Drug for COVID Use
The European Medicines Agency will conduct an accelerated review of Eli Lilly's rheumatoid arthritis drug Olumiant for hospitalized COVID-19 patients getting oxygen, the agency said.Reuters Health Information (Source: Medscape Orthopaedics Headlines)
Source: Medscape Orthopaedics Headlines - April 30, 2021 Category: Orthopaedics Tags: Infectious Diseases News Source Type: news

EU Will Allow Fully Vaccinated U.S. Tourists
MONDAY, April 26, 2021 -- American tourists who are fully vaccinated against COVID-19 will be allowed to visit the European Union over the summer, a top official said Monday. " The Americans, as far as I can see, use European Medicines Agency... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 26, 2021 Category: Pharmaceuticals Source Type: news

Johnson & Johnson Statement on April 23 CDC Advisory Committee Meeting on Company COVID-19 Vaccine
NEW BRUNSWICK, N.J., April 23, 2021 – The U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) today voted to resume use of the Johnson & Johnson COVID-19 vaccine in persons 18 years of age and older in the U.S. population under the U.S. Food and Drug Administration’s (FDA) Emergency Use Authorization.Statement from Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson:“We are grateful to the Advisory Committee and its medical experts for the rigorous evaluation of our COVID-19 vaccine. T...
Source: Johnson and Johnson - April 23, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

EU agency says people should get 2nd dose of AstraZeneca too
The European Medicines Agency says people who have received a first dose of AstraZeneca’s COVID-19 vaccine should also get the second one despite the rare risk of blood clots that have been linked to the shot (Source: ABC News: Health)
Source: ABC News: Health - April 23, 2021 Category: Consumer Health News Tags: Health Source Type: news

Roche announces positive CHMP opinion for Venclyxto-based combinations in certain patients with acute myeloid leukaemia
Basel, 23 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency ’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Venclyxto® (venetoclax) in combination with a hypomethylating agent for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy. Bas ed on this positive CHMP recommendation, a final decision regarding the approval of Venclyxto in certain patients with untreated AML is expected from the European Commission in the near future.“Today’s...
Source: Roche Investor Update - April 23, 2021 Category: Pharmaceuticals Source Type: news

CHMP recommends EU approval of Roche ’s ENSPRYNG (satralizumab) for adults and adolescents with neuromyelitis optica spectrum disorder (NMOSD)
Basel, 23 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of ENSPRYNG® (satralizumab) as the first subcutaneous treatment option for adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spe ctrum disorder (NMOSD), as a monotherapy or in combination with immunosuppressive therapy (IST). AQP4-IgG are present in around 70-80% of people with NMOSD, who tend to experience a more severe disease course.NMOS...
Source: Roche Media News - April 23, 2021 Category: Pharmaceuticals Source Type: news

CHMP recommends EU approval of Roche ’s ENSPRYNG (satralizumab) for adults and adolescents with neuromyelitis optica spectrum disorder (NMOSD)
Basel, 23 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of ENSPRYNG® (satralizumab) as the first subcutaneous treatment option for adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spe ctrum disorder (NMOSD), as a monotherapy or in combination with immunosuppressive therapy (IST). AQP4-IgG are present in around 70-80% of people with NMOSD, who tend to experience a more severe disease course.NMOS...
Source: Roche Investor Update - April 23, 2021 Category: Pharmaceuticals Source Type: news

European Medicines Agency to issue more guidance on AstraZeneca's COVID-19 shot
Earlier this month, the Amsterdam-based drug regulator for the 27-nation European Union said there was a "possible link" between the AstraZeneca vaccine and rare blood clotting disorders, but that the benefits of getting the shots outweighed the risks. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - April 23, 2021 Category: Pharmaceuticals Source Type: news

Health officials lean toward resuming Johnson & Johnson coronavirus vaccine — but with a warning
The position would be similar to one taken by Europe’s drug regulator, the European Medicines Agency, which said this week the Johnson & Johnson vaccine should carry a warning but placed no restrictions on its use. (Source: Washington Post: To Your Health)
Source: Washington Post: To Your Health - April 22, 2021 Category: Consumer Health News Authors: Laurie McGinley Source Type: news

European regulators slap safety warning on JJ vaccine over deadly blood clots
(Natural News) The European Medicines Agency (EMA) has changed course and decided to issue a safety warning concerning the Wuhan coronavirus (Covid-19) injection from Johnson & Johnson (J&J), which has been linked to deadly blood clots. The group had formerly claimed that the AstraZeneca-Oxford jab, which also causes deadly blood clots, is far more beneficial... (Source: NaturalNews.com)
Source: NaturalNews.com - April 22, 2021 Category: Consumer Health News Source Type: news

Johnson & Johnson Statement on FDA Observations at Emergent BioSolutions (Updated 4/30)
NEW BRUNSWICK, N.J., April 21, 2021 – The quality and safety of our COVID-19 vaccine is paramount. On April 3, 2021, Johnson & Johnson announced it would increase its oversight of drug substance manufacturing at the Emergent BioSolutions Bayview facility, including additional controls and personnel, to ensure the quality standards of our company and the U. S. Food & Drug Administration (FDA) are met. Since then, the Company has worked closely with the U.S. government, including the FDA, and with the European Medicines Agency (EMA), concerning the FDA inspection at Emergent Bayview, which concluded on Tuesday,...
Source: Johnson and Johnson - April 21, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

J & amp;J COVID - 19 Vaccine Should Be Used, but Carry Blood Clot Warning
European Medicines Agency also said the vaccine's benefits still far outweigh its risks (Source: The Doctors Lounge - Oncology)
Source: The Doctors Lounge - Oncology - April 21, 2021 Category: Cancer & Oncology Tags: Family Medicine, Geriatrics, Gynecology, Infections, Internal Medicine, Emergency Medicine, Nursing, Oncology, Pharmacy, Institutional, Source Type: news

J & J COVID-19 Vaccine Should Be Used, but Carry Blood Clot Warning
TUESDAY, April 20, 2021 -- A warning about a possible link to rare blood clots should be added to the Johnson& Johnson/Janssen single-dose COVID-19 vaccine, the European Union (EU) drug regulator said Tuesday. But the European Medicines Agency... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 20, 2021 Category: Pharmaceuticals Source Type: news

J&J to restart vaccine shipments to Europe after regulatory green light
European Medicines Agency says jab’s benefits still outweigh risks despite blood clot concerns (Source: FT.com - Drugs and Healthcare)
Source: FT.com - Drugs and Healthcare - April 20, 2021 Category: Pharmaceuticals Source Type: news

E.U. regulator finds possible link between J & J Covid vaccine and blood clots
The European Medicines Agency said the "overall benefits" of the J&J vaccine still outweigh the risks of side effects. (Source: Reuters: Health)
Source: Reuters: Health - April 20, 2021 Category: Consumer Health News Source Type: news

Possible link between J & J Covid vaccine and rare blood clots, EU regulator finds
Watchdog says benefits outweigh risks but that warning should be added to product informationCoronavirus – latest updatesSee all our coronavirus coverageEurope ’s medicines regulator has found a possible link between Johnson& Johnson ’s coronavirus vaccine and rare cases of unusual blood clotting disorders it said were “very similar” to those that had occurred with the AstraZeneca shot.The European Medicines Agency (EMA) on Tuesday recommended a warning should be added to the vaccine ’s product information, but stressed that the benefits of the shot – which was put on hold last...
Source: Guardian Unlimited Science - April 20, 2021 Category: Science Authors: Jon Henley and Ian Sample Tags: Vaccines and immunisation Coronavirus Health Society Science Infectious diseases Medical research World news Source Type: news

Johnson & Johnson COVID-19 Vaccine Roll-out to Resume in Europe Following European Medicines Agency (EMA) ReviewEMA Confirms Overall Benefit-Risk Profile Remains Positive
NEW BRUNSWICK, N.J., April 20, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has provided updated guidance for use of the Company’s COVID-19 vaccine and confirmed the overall benefit-risk profile remains positive. The guidance follows PRAC review of a small number of cases of a very rare adverse event involving blood clots in combination with low platelet counts that can occur within approximately one to three weeks following injection with the Company’s COVID-19 vaccine. As a resul...
Source: Johnson and Johnson - April 20, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

European Union Regulator Says Benefits Outweigh Risks Of Johnson & Johnson Vaccine
The European Medicines Agency says there is a possible link between the J&J vaccine and rare blood clotting. It says a warning should be added to the label, but says benefits outweigh the risks. (Source: NPR Health and Science)
Source: NPR Health and Science - April 20, 2021 Category: Consumer Health News Authors: Jason Beaubien Source Type: news

AstraZeneca's COVID-19 vaccine: European Medicines Agency to provide further context on risk of very rare blood clots with low blood platelets, EMA
The review by CHMP will enable authorities to put the risks of the vaccine into the context of the benefits of ongoing vaccination campaigns. It will also consider whether to update recommendations for a second dose in those who have already received the first dose. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - April 20, 2021 Category: Consumer Health News Source Type: news

COVID-19 Vaccine Janssen: European Medicines Agency's assessment of very rare cases of unusual blood clots with low platelets continues, EMA
The European Medicines Agency is expediting this evaluation and currently expects to issue a recommendation next week. While its review is ongoing, it remains of the view that the benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - April 20, 2021 Category: Consumer Health News Source Type: news

Blood clots should be listed as rare Johnson & Johnson side effect, says Europe drug watchdog
The European Medicines Agency (EMA) said in a statement that it had found a "possible link" between the jab and the clots, following eight such cases in the United States, one of which was fatal. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - April 20, 2021 Category: Pharmaceuticals Source Type: news