Tag: Pfizer

Older and high-risk populations can now receive Pfizer vaccine booster dose, FDA says

Frank

USA – People above 65 years and adults at high risk of severe COVID-19 infection are now eligible to receive Pfizer/BioNTech’s booster dose vaccine, following emergency use authorization by the Food and Drug Administration (FDA). The decision paves the way for millions of people who received their second dose of the vaccine at least six months ago to receive booster shots as soon as they can. This emergency use authorization was based on the totality of scientific evidence shared by the companies and reviewed by the FDA’s Vaccines and Related…

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Pfizer/BioNTech say data shows COVID-19 vaccine safe and protective in kids

Frank

USA – Pfizer Inc and BioNTech SE have said their COVID-19 vaccine induced a robust immune response in 5 to 11-year-olds, and they plan to ask for authorization to use the vaccine in children in that age range in the United States, Europe, and elsewhere as soon as possible. The companies said the vaccine generated an immune response in the 5-to-11-year-olds in their Phase II/III clinical trial that matched what they had previously observed in 16-to-25-year-olds. The safety profile was also generally comparable to the older age group, they said.…

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SAPHRA approves Pfizer vaccine for children over 12 in South Africa

Frank

SOUTH AFRICA – The South African Health Products Authority (SAPHRA) has approved Pfizer’s COVID-19 vaccine for use by children aged 12 and older, paving the way for the government to offer vaccinations to teenagers. The move follows a review of updated safety and efficacy information and doesn’t translate into a procurement decision, the South African health regulator said. Regulators approved the vaccine developed by Pfizer and BioNTech for local use in adults in March. Africa’s most developed country has been the hardest hit by the pandemic, reporting the highest number…

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France to donate 10 million vaccines to Africa over three months

Frank

AFRICA – France has committed to provide the African continent with 10 million doses of AstraZeneca and Pfizer vaccines over the next three months following a new partnership between France and the African Union. The vaccines will be allocated and distributed in the framework of the AU’s African Vaccine Acquisition Trust (AVAT) and the partnership for equitable vaccine rollout known as Covax, according to a statement issued by the Elysée palace. “The Covid-19 pandemic can only be overcome through intense cooperation,” Macron said in the statement, emphasising France’s “solid partnership”…

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Pfizer becomes first ever COVID-19 vaccine to gain FDA’s full approval

Frank

USA – The Food and Drug Administration (FDA) has granted full approval to Pfizer’s COVID-19 vaccine for individuals 16 years and older, and will now be marketed as Comirnaty. The approval is expected to set off more vaccine mandates by employers and organizations across the USA. It comes amid lingering vaccine hesitancy among many Americans. Even so, out of more than 170 million people in the United States fully vaccinated against Covid-19, more than 92 million have received the Pfizer/BioNTech vaccine. In a statement, the FDA said its review for…

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Pfizer/BioNTech COVID-19 vaccine set to receive full US FDA approval

Frank

USA – The U.S. Food and Drug Administration has made public its aim to give full approval to Pfizer’s COVID-19 vaccine this coming week.   Previously, the regulator had set a deadline for September sixth, during which they would give the approval. This approval could boost the vaccination campaign by convincing more unvaccinated Americans that Pfizer’s shot is safe and effective and also make local officials more comfortable in implementing vaccine mandates. The U.S. military is expected to require that service members get vaccinated soon after Pfizer’s shot is authorized…

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Pfizer expands recall of anti-smoking drug over carcinogen presence

Frank

USA – Pfizer has said it is recalling four additional lots of its anti-smoking treatment, Chantix, after finding elevated levels of cancer-causing agents called nitrosamines in the pills. In June, the drug maker said it was pausing distribution of certain lots of the anti-smoking drug out of an abundance of caution and pending further testing. The Food and Drug Administration last year found high levels of NDMA in some versions of the popular diabetes drug metformin. NDMA contamination was responsible for the recall of heartburn drug Zantac sold by Sanofi…

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Pfizer and Moderna ramp up prices for their COVID-19 vaccines

Frank

EUROPE – Pfizer Inc and Moderna Inc have raised the prices of their COVID-19 vaccines in their latest European Union supply contracts, the Financial Times has reported. The new price for the Pfizer shot was 19.50 euros (US$23.15) against 15.50 euros previously, the newspaper said, citing portions of the contracts seen. The price of a Moderna vaccine was US$25.50 a dose, the contracts show, up from about 19 euros in the first procurement deal but lower than the previously agreed US$28.50 because the order had grown, the report said, citing…

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Ghana approves Moderna, Pfizer as Zimbabwe approves Johnson&johnson COVID-19 vaccine

Frank

GHANA – Ghana’s Foods and Drugs Authority (FDA) has approved the importation and use of Moderna Spikevax and Pfizer-BioNTech’s coronavirus vaccines in the country. The approval of these two now brings the number of approved vaccines in Ghana to five, all in a bid to protect citizens from the pandemic. “The FDA continues to use the emergency authorization pathway, which is the accepted procedure for all national regulatory authorities globally, to ensure timely access to quality and safe medical products including vaccines during this pandemic,” said the release by FDA.…

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Research shows extended periods between dose administration of Pfizer vaccine boosts antibodies

Frank

US – Based on findings from a UK research, it was discovered that extending the time between the first and second doses of the Pfizer/BioNTech COVID-19 vaccine boosted antibodies against all variants of the virus tested compared to a short dosing interval. They found that a longer dosing interval led to two times higher neutralizing antibodies against all variants, including the Delta variant, compared to the short dosing schedule. The Protective Immunity from T cells to COVID-19 in Health workers study (PITCH) examined how antibody and T cell levels change…

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