A supposed leaked document on adverse events to Pfizer's Covid-19 vaccine has dominated South African Twitter trends this week. However, Pfizer says the ...
“It is important to note that serious adverse events that are unrelated to the vaccine are unfortunately likely to occur at a similar rate as they would in the general population,” said Angira. “Unfortunately we cannot authenticate documents that are being circulated on social media. “Pfizer takes adverse events that are potentially associated with our Covid-19 vaccine very seriously.
PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) is the first oral therapy specifically designed to combat COVID-19 to be evaluated in a ...
PAXLOVID is not recommended in patients with severe renal impairment (eGFR <30 mL/min based on CKD-EPI formula) until more data are available; the appropriate dosage for patients with severe renal impairment has not been determined. This statement contains forward-looking information about Pfizer’s efforts to combat COVID-19 and PAXLOVID (including a Phase 2/3 study in pediatric patients, a potential age-appropriate formulation for three additional planned cohorts of younger than 6 years old, qualitative assessments of available data, potential benefits, expectations for clinical trials, advance purchase agreements and an agreement with MPP, efforts toward equitable access, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations, potential to maintain antiviral activity against current variants of concern, planned investment and anticipated manufacturing, distribution and supply), involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. The safety and effectiveness of PAXLOVID have not been established in pediatric patients. There is no information on the effects of ritonavir on the breastfed infant or the effects of the drug on milk production. Lactation: There are no available data on the presence of nirmatrelvir in human or animal milk, the effects on the breastfed infant, or the effects on milk production. PAXLOVID is contraindicated with drugs that are potent CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance. Co-administration with a low dose of ritonavir helps slow the metabolism, or breakdown, of nirmatrelvir in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus. At the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. FDA, Pfizer ceased further enrollment into the study in early November 2021 due to the overwhelming efficacy demonstrated in these results. Treatment-emergent adverse events were comparable between PAXLOVID (23%) and placebo (24%), most of which were mild in intensity. Additionally, Pfizer has signed a voluntary license agreement with the Medicines Patent Pool (MPP) for its oral treatment to help expand access, pending country regulatory authorization or approval, in 95 low- and middle-income countries that account for approximately 53% of the world’s population. Treatment-emergent adverse events were comparable between PAXLOVID (23%) and placebo (24%), most of which were mild in intensity. The safety and effectiveness of PAXLOVID have not yet been directly established in pediatric patients.
Drugmaker expects results from its study of Paxlovid in high-risk children by end of year.
Pfizer also will collect blood samples from the children to assess how much of the virus declines over time. Remove some to bookmark this image. Yet children were hospitalized in larger numbers during the recent Omicron surge than previously in the pandemic. Paxlovid is taken twice daily over five days. The study will evaluate whether Paxlovid reduces the risk that the young study subjects will be admitted to a hospital or die within a month of taking the treatment. Uptake of vaccines for children under 12 years has been slower than authorities had hoped, and the FDA has delayed making a decision whether to authorize a shot for children under 5.
Pfizer announced Wednesday that it has started a clinical trial testing its Covid-19 antiviral pill in children as young as 6.
Even though children are less likely than adults to be hospitalized or die from the virus, some of them do. Both groups will receive a full course of Pfizer's treatment — taken as three pills twice daily for five days. Children in the U.S. account for roughly 1 percent to 4 percent of those hospitalized from Covid and less than 1 percent of deaths, according to data from the American Academy of Pediatrics.
Pfizer announced Wednesday that it has initiated a phase 2/3 study of its COVID-19 antiviral for pediatric patients.
A second cohort of children weighing between 20 kg and 40 kg will also receive the therapy orally twice daily for 5 days, but with a reduced dose of nirmatrelvir (150 mg). “Paxlovid is already authorized or approved in many countries around the world, with more than 1.5 million treatment courses delivered thus far and 30 million expected by July to help combat this devastating disease,” he said. The first will include children weighing at least 40 kg, who will receive 300 mg of nirmatrelvir and 100 mg of ritonavir orally twice daily for 5 days — the currently authorized dose for patients aged 12 years and older weighing at least 40 kg.
Just under a third of South Africa's remaining Covid-19 vaccines from Pfizer are set to expire by July. After that, any unused doses will have to be ...
Wastage is the highest in Northern Cape (2.9%), where cold-chain storage is a challenge and jabs have to be transported for long distances to sites. This is because workers at vaccination sites sometimes don’t manage to extract all the doses from a vial, because a vial gets opened towards the end of the day and there are then not enough people at a site to consume all the doses. They help with practical interventions so that people do not have to travel, pay for transport or spend a lot of time getting vaccinated,” said Dhirisha Naidoo of BroadReach. Of the vaccines that have been distributed to provinces, 92% (32,027,146 of 34,965,340 distributed doses) had made it into people’s arms by March 6. South Africa’s vaccination rate declined quite significantly over the December holidays and it struggled to pick up thereafter. “We’ve let them know we potentially have five million vaccines available, but haven’t had any formal offers. Just under a third of South Africa’s remaining Covid-19 vaccines from Pfizer are set to expire by July. After that, any unused doses will have to be destroyed. From there, the jabs are transported to either public sector provincial warehouses or private sector companies that do vaccinations. Sometimes jabs were also not stored at the correct temperatures or used before they expired. “We’ll see what the uptake looks like, and if needed, we’ll ask for our doses from Covax,” says Nicholas Crisp, who heads up South Africa’s roll-out in the national health department. The remaining jabs (10,619,800) will be delivered during the course of this year. Moreover, the health department is negotiating with Covax and the African Vaccine Acquisition Trust (Avat, the African Union’s vaccine initiative) to see if it’s possible to swap some of South Africa’s vaccines that will expire in June and July for vaccines that will expire at a later date, says Crisp. That way, countries that don’t currently have vaccines can use South Africa’s and then return jabs to the country via Covax at a later stage.
The chief executive of pharmaceutical giant Pfizer says his company does not have plans to invest further in Russia, as that nation's invasion of Ukraine is ...
"We do not expect to see in the world any disruptions, right now at least, because of this war." Less than half a percent of the company's total revenue comes from Russia, Bourla said. "We are very independent in terms of our supplying our ingredients from those parts of the world," Bourla said.
Pfizer said on Wednesday it has begun a mid-to-late-stage study of its antiviral COVID-19 pill for non-hospitalized children aged 6-17 years who are at high ...
Register now for FREE unlimited access to Reuters.com Pfizer's Paxlovid pill is authorized for emergency use in the United States for kids 12 years or older and high-risk adults. Register now for FREE unlimited access to Reuters.com
Pfizer on March 9 said it has started phase 2 and 3 trials evaluating its COVID-19 antiviral Paxlovid in children.
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To date, there have been 17-million people vaccinated in South Africa. This is still a very small amount of people, as it's only 29% of the country's ...
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