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Monday, dec 23
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Pfizer
News
FDA Approves Updated
Covid-
19 Vaccines: Here's When They Will Be Available
The US Food and Drug Administration has just approved new COVID-19 vaccines.It marks the third time the vaccines from Pfizer and Moderna have been updated to match circulating strains since the original shot. The shots should be available within days, the FDA said in making the announcement Thursday afternoon, Aug. 22. The new vaccines have been updated with a formula to more closely target currently circulating variants and provide better protection against serious consequences of COVID, including hospitalization and death. “Vaccination continues to be the cornerstone of COVID-19 preventi…
News
Covid-
19: FDA Approves Updated Booster Shots Targeting New Variants
Health officials are one step closer to rolling out updated COVID-19 vaccines just in time for a rise in cases heading into the fall and winter months. The US Food and Drug Administration (FDA) approved new vaccines on Monday, Sept. 11, that are meant to better target currently circulating COVID-19 variants and provide better protection against hospitalization and death, the agency announced. Monday’s move affects vaccines manufactured by Moderna and Pfizer. The updated mRNA vaccines are each approved for people ages 12 and older and are authorized under emergency use for children ages 6 mo…
News
Covid-
19: Vaccine Targeting Omicron Variant Authorized For Young Children By FDA
The Food and Drug Administration has authorized the use of updated COVID-19 booster shots targeting the Omicron variant for younger children. The FDA announced the amended emergency use authorization of the bivalent Moderna and Pfizer booster vaccines on Wednesday, Oct. 12. Today, FDA amended the EUA of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups. https://t.co/C2Sx5Nkk0R pic.twitter.com/xsPfO2Mek3 — U.S. FDA (@US_FDA) October 12, 2022 The Moderna bivalent booster is autho…
News
Covid-
19: New Booster Shots Targeting Omicron Variant Approved By FDA
It’s time to roll up your sleeve and get another COVID-19 vaccine. On Wednesday, Aug. 31, the US Food and Drug Administration (FDA) approved updated versions of COVID booster shots made by Pfizer and Moderna that target the highly contagious BA.5 Omicron subvariant. The updated vaccine boosters are designed to give people broad protection against COVID and can help protect against severe illness, hospitalization, and death, the FDA said in a statement. Pfizer’s modified booster was authorized for people ages 12 and older, while Moderna’s shot was approved for those 18 and up. People who…
News
Covid-
19: Vaccines For Kids Under 5 Unanimously Recommended By Expert FDA Panel
Federal health officials are moving closer to authorizing COVID-19 vaccines for the youngest Americans. The US Food and Drug Administration (FDA) voted on Wednesday, June 15 to recommend authorizing both the Moderna and Pfizer COVID-19 vaccines for children between the ages of 6 months and 5 years old. On Wednesday, the agency’s independent panel of experts voted to recommend the vaccines - which are currently only available for Americans 5 years and older - for younger children. All 21 members of the FDA's Vaccines and Related Biological Products Advisory Committee unanimously voted to a…
Business
Pfizer Pills Recalled Due To Increased Cancer Risk
Pfizer has issued a recall for blood pressure pills that were distributed across the United States due to the presence of an organic compound it said could increase the risk of cancer. The five lots of Accupril (Quinapril HCl) tablets distributed by Pfizer to the patient level due to the presence of a nitrosamine, Nnitroso-quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level, the Food and Drug Administration announced. "These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time," the FDA sai…
News
Covid-
19: FDA Authorizes Second Booster Shot For This Group Of Americans
Federal health officials authorized a second booster shot of both the Pfizer and Moderna COVID-19 vaccines for older Americans. On Tuesday, March 29, the Food and Drug Administration (FDA) announced that a second shot has been approved for Americans who are 50 and older once four months have passed since their initial booster. With the FDA's approval, the decision now falls on Dr. Rochelle Walensky, the director of the Centers for Disease Control and Prevention (CDC), who is expected to sign off on the additional shot as soon as Tuesday afternoon. The second booster shot had already been …
News
Covid-
19: FDA Expected To Authorize Second Booster Shot For This Age Group Within Days
The United States Food & Drug Administration is expected to authorize a second COVID-19 booster shot for some Americans within the next few days, according to multiple reports. CNN reported on Saturday, March 26, that sources said the FDA plans to authorize the additional booster shot for people ages 50 and older in the coming days. An anonymous official told The Washington Post that the authorizations for the additional Moderna and Pfizer booster shots could be announced as soon as Tuesday, March 29. CNN reported that the CDC is expected to give a permissive recommendation following F…
Business
Pfizer Recalls Blood Pressure Medicines Over Carcinogen
Pfizer announced a nationwide recall of blood pressure medication that could potentially contain cancer-causing carcinogens. The pharmaceutical giant announced that it was recalling certain lots of the blood pressure drug Accuretic and two authorized cheaper versions of the drug due to the presence of elevated levels of a nitrosamine, an impurity that could cause cancer. “Nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables,” Pfizer officials announced. “Everyone is exposed to some level of nitrosamines. These impurities may increase …
News
Covid-
19: Moderna Seeks Approval For Second Booster Shot For All Adults
Though the COVID-19 case numbers across the country have either plateaued or are showing improvement, Moderna is now seeking federal approval to administer a second booster shot for adults. Moderna is seeking an amendment of the US Food and Drug Administration’s emergency use authorization for its COVID-19 vaccine to allow for a fourth vaccine to adults 18 and older who have gotten an initial booster. The move by Moderna comes days after Pfizer and BioNTech submitted a similar request for authorization of an additional booster shot, though that vaccine would only be eligible for adults 65 a…
News
Covid-
19: 'Many Variants Are Coming,' Pfizer CEO Warns, Saying Fourth Shot Will Be Needed
Warning that "many variants are coming," the chairman and chief executive officer of Pfizer says a fourth dose of the COVID-19 -- a second booster shot -- will be needed. Appearing on CBS-TV's "Face the Nation" on Sunday, March 13, Dr. Albert Bourla was asked if a COVID booster shot could become recommended each fall - similar to a flu shot. "I think so," Bourla responded. "And I think this is what we are trying now to make." Bourla said Pfizer is trying "very diligently to stay ahead of the virus" because "many variants are coming and Omicron was the first one that was able to evade in a …
News
Covid-
19: FDA Changes Course On Vaccine Authorization For Kids Under 5
Federal health officials delayed a planned public meeting to review Pfizer’s COVID-19 vaccine for children under five. Citing the need to see more data as part of its rolling application process, the Food and Drug Administration (FDA) announced on Friday, Feb. 11 that it would be delaying the planned meeting, raising questions about how soon children should get the COVID-19 shot. The FDA’s outside experts had been set to meet on Tuesday, Feb. 15 to discuss if children under the age of 5 could safely receive a low dose of the vaccine safely. Pfizer said on Friday that it will be waiting fo…
News
Covid-
19: Johnson & Johnson Pauses Vaccine Production, Reports Say
The only Johnson & Johnson facility currently making viable batches of the company's one-dose COVID-19 vaccine has temporarily halted its production, according to a new report. According to The New York Times, Johnson & Johnson has stopped production of its current vaccine, potentially to create a more profitable version aimed at other viruses. With production on hold at its Dutch facility in the city of Leiden, hundreds of millions of doses could be taken out of circulation, though it is unclear how vaccine supplies in the US have been affected. Ayoade Alakija, a co-head of the A…
News
Covid-
19: Pfizer Asks FDA For Emergency Use Authorization Of Vaccine For Children Under 5
New York-based Pfizer and its European partner BioNTech has requested that the Food and Drug Administration (FDA) expand the use of its COVID-19 vaccine to include children between the ages of 6 months and 5 years old, officials announced. On Tuesday, Feb. 1, citing a host of clinical trials, the pharmaceutical company announced it is seeking emergency use authorization (EUA) to admit the vaccine to a wider range of children. Currently, the vaccine is only approved for children 5 years old and older. Pfizer said that it plans to complete its EUA submission “in the coming days,” and has alre…
News
Covid-
19: Moderna Vaccine Gets Full Approval From FDA
Federal officials have granted full approval to Moderna’s COVID-19 vaccine following its authorization last year for emergency use. On Monday, Jan. 31, the Food and Drug Administration (FDA) announced that Moderna’s vaccine has been granted its full approval, joining the Pfizer shot which was authorized months ago. The move comes after tens of millions of doses of the Moderna vaccine have already been administered across the country. It also represents Moderna’s first FDA-approved product in the US. Officials said the FDA reviewed months of additional follow-up data submitted by Moderna to…
Business
Covid-
19: Pfizer Launches Clinical Trial For Vaccine Targeting Omicron Variant
New York-based Pfizer and its European partner BioNTech have launched a clinical study to evaluate a COVID-19 vaccine that specifically targets the Omicron variant. The study will evaluate the safety and efficacy of an Omicron-based vaccine among healthy adults ages 18 through 55, Pfizer announced on Tuesday, Jan. 25. According to a recent update from the Centers for Disease Control and Prevention (CDC), the Omicron variant is estimated to have accounted for 99.5 percent of circulating variants of COVID-19 in the United States between Sunday, Jan. 9, and Saturday, Jan. 15. Pfizer said up t…
News
Covid-
19: Pfizer CEO Announces When Vaccine Targeting Omicron Variant Will Be Ready
A vaccine targeting the highly transmissible Omicron COVID-19 variant could be on the way from Pfizer. On Monday, Jan. 10, Pfizer CEO Albert Bourla said that booster targeting Omicron will be ready as soon as March, as the company has already begun ramping up production of the doses. “This vaccine will be ready in March,” Bourla told CNBC’s “Squawk Box.” “We (are) already starting manufacturing some of these quantities at risk.” Related story - COVID-19: Fauci Offers New Prediction On When Omicron Wave May Break The vaccine will not exclusively target Omicron, but will also be able to fig…
News
Covid-
19: FDA Authorizes Second Antiviral Pill
For the second time in as many days, the Food and Drug Administration (FDA) has authorized the use of an antiviral pill to treat mild and moderate COVID-19 cases. On Thursday, Dec. 23, the FDA approved the use of Merck’s molnupiravir pill for emergency use authorization, a day after officials authorized the use of Pfizer’s COVID-19 treatment pill. Earlier story - COVID-19: FDA OKs First Authorized Home Treatment For Virus Merck’s pill has been cleared for use by adults 18 and older who have tested positive for COVID-19 and are at the greatest risk of being hospitalized or dying from t…
News
Covid-
19: FDA OKs First Authorized Home Treatment For Virus
The fight against COVID-19 took a step forward as federal health officials authorized the first pill that Americans will be able to take at home to head off the worst effects of the virus. On Wednesday, Dec. 22, the US Food and Drug Administration (FDA) granted emergency authorization for Pfizer’s COVID-19 treatment pill, which has been recommended for people at high risk of developing severe cases of COVID-19. The pill could be available as soon as this weekend, according to Pfizer CEO Albert Bourla. Related story - COVID-19: Pfizer Releases Data On Anti-Viral Pill's Effective…
News
Covid-
19: CDC Panel Recommends Moderna, Pfizer Vaccines Over Johnson & Johnson Jab
The Centers for Disease Control and Prevention (CDC) issued new guidance saying that people shouldn’t get the one-dose Johnson & Johnson COVID-19 shot if the Pfizer or Moderna option is available. Citing potentially life-threatening blood clots liked to the J & J jab, the CDC’s Advisory Committee on Immunization Practices (ACIP) met on Thursday, Dec. 16 following an update from the Food and Drug Administration. Federal officials halted the use of the Johnson & Johnson vaccine earlier this year for 10 days in April after six women experienced the blood-clotting problem — the only…
News
Covid-
19: Pfizer Releases Data On Anti-Viral Pill's Effectiveness Vs. Omicron, Severe Disease
Brand-new laboratory studies are shedding light on the effectiveness of Pfizer's anti-viral COVID-19 pill both against the Omicron variant and in warding off severe disease. The studies showed the pill, called Paxlovid, reduced the risk of hospitalization or death by nearly 90 percent if given to high-risk adults within several days of their initial COVID symptoms, Pfizer said in a statement released Tuesday morning, Dec. 14. The pill also retains activity against variants, including Omicron, because the drug blocks an enzyme involved in viral replication, Pfizer said. “Emerging …
News
Covid-
19: Fourth Shot May Eventually Be Needed, Pfizer Says
The CEO of Pfizer said in an interview that he believes a fourth COVID-19 vaccine dose will eventually be needed. Albert Bourla said on CNBC that real-world data will help determine how well three doses of the vaccine protect against the Omicron variant and how long protection lasts. "And the second point, I think we will need the fourth dose," Bourla told CNBC on Wednesday, Dec. 8. "I’ve said that multiple times. With the previous, I was projecting that that will be on 12 months after the third dose. With Omicron, we need to wait and see because we have very little informat…
News
Covid-
19: FDA Expands Booster Vaccine Eligibility To Include Ages 16 & 17
The United States Food and Drug Administration (FDA) has expanded eligibility for Pfizer's COVID-19 booster vaccines to include 16- and 17-year-olds. The FDA said in an announcement on Thursday, Dec. 9, that it has amended the emergency use authorization of the booster vaccine to include those aged 16 and older at least six months after they've completed their primary vaccination. “Vaccination and getting a booster when eligible, along with other preventive measures like masking and avoiding large crowds and poorly ventilated spaces, remain our most effective methods for fighting COVID-19,”…
News
Covid-
19: First Findings Released On Vaccine Effectiveness Against Omicron Variant
The first findings on the effectiveness of vaccines against the COVID-19 Omicron variant have been released. Pfizer and its European partner BioNTech said that a booster shot offers significant protection against Omicron and "neutralizes" the strain. Two vaccine doses "show significantly reduced neutralization titers" but could protect against severe disease from COVID, the companies said. The findings come from an initial laboratory study. According to the companies’ preliminary data, "a third dose provides a similar level of neutralizing antibodies to Omicron as is observ…
News
Covid-
19: Pfizer CEO Says New Vaccine May Be Needed For Omicron, Anti-Viral Pills Are Effective
Pfizer CEO Albert Bourla said that his company is preparing to tackle new COVID-19 variants, and that he expects the company’s treatment pill will be effective in helping avoid severe illness or possibly death if one get infected. According to the World Health Organization (WHO), Omicron poses a “very high” global risk, with the likelihood it is more transmissible than previous strains. The new variant has nearly three dozen mutations that reportedly decrease antibody protection. WHO described Omicron as a “highly divergent variant with a high number of mutations ... some of which are conce…
News
Covid-
19: FDA Clears Moderna, Pfizer Boosters For All US Adults
Federal health officials have given the green light for all Americans to get COVID-19 booster shots for all adults. The Food and Drug Administration (FDA) authorized Moderna and Pfizer COVID-19 booster shots for all adults in the US 18 and older, paving the way for expanding the eligibility of boosters in advance of the holiday season. Previously, the FDA had only authorized booster shots for Americans 65 and older, and those who were at a high risk of contracting COVID-19 due to pre-existing conditions of their job. “Authorizing the use of a single booster dose of either the Moderna or Pf…
Business
Covid-
19: People Who Spread Misinfo About Vaccines Are ‘Criminals,' Pfizer CEO Says
Pfizer CEO Albert Bourla has harsh words for the “criminals” who have intentionally spread misinformation about COVID-19 vaccines. Speaking with Atlantic Council think tank CEO Frederick Kempe this week, Bourla said that a “very small” group of people spreading misinformation has cost millions of lives. “These people are criminals,” Bourla said. “They’re not bad people. They’re criminals because they have literally cost millions of lives.” Related story - COVID-19: Pfizer Expected To Seek Approval For Boosters For All Adults Bourla went on to say that “the only thing that stands betw…
News
Covid-
19: Pfizer Expected To Seek Approval For Boosters For All Adults
Pfizer and European partner BioNTech are expected to seek federal authorization to administer its COVID-19 booster shot to all Americans over the age of 18. As soon as this week, the biopharmaceutical company is reportedly planning to seek US Food and Drug Administration (FDA) approval for booster shots for anyone 18 and older. Currently, only Americans 65 and older, those who are immunocompromised and anyone whose job puts them at a larger risk for exposure are eligible for Pfizer booster shots. The FDA is considered likely to grant the request, potentially before Thanksgiving and the hol…
News
Covid-
19: Walgreens Opens Vaccine Appointments For Children Ages 5 To 11
Walgreens has opened up appointments at thousands of locations across the United States for children ages 5 to 11 to receive the newly-authorized Pfizer COVID-19 vaccine. The company announced on Wednesday, Nov. 3, that the lower dose vaccine would be available at certain locations beginning Saturday, Nov. 6. Walgreens said parents or guardians can schedule appointments on the Walgreens website, on the app or by calling 1-800-Walgreens. More appointments will be made available as stores receive additional vaccine shipments, the company said. “Walgreens pharmacy team members have sig…
News
Covid-
19: Here's When General Public Likely Will Need To Get Boosters, Dr. Fauci Says
COVID-19 booster shots could soon be made available to all Americans. Dr. Anthony Fauci, one of the country’s foremost authorities on infectious diseases, said this week that Pfizer and Moderna boosters could be coming for all, not just certain groups that are currently eligible. Currently, Americans who are over the age of 65, those who are immunocompromised, and anyone who is frequently exposed to the virus through work is eligible for the COVID-19 booster shots six months after receiving their second dose. According to Fauci, it is expected that everyone will eventually need booster sh…
News
Covid-
19: CDC Panel Recommends Vaccine For Kids Ages 5 To 11
A Centers for Disease Control and Prevention (CDC) panel has voted to recommend the Pfizer COVID-19 vaccine for children ages 5 to 11. The panel of vaccine advisers voted unanimously in favor of the recommendation on Tuesday afternoon, Nov. 2. CDC Director Dr. Rochelle Walensky is expected to accept the recommendation before the vaccinations can begin for the age group, perhaps as early as Wednesday, Nov. 3. The dose will be much lower than the company's vaccine for teenagers and adults, about one-third of a full dose, according to reports.
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