Category: Corona Virus Vaccine

September 22, 2021: FDA authorizes Pfizer-BioNTech COVID-19 Vaccinebooster dose for certain populations.View press release.

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The U.S. Food and Drug Administration approved Comirnaty for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older. The vaccine has the same formulation as the Pfizer-BioNTech COVID-19 Vaccine that continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age,for the administration of a third dose in certain immunocompromised individuals, and for a single booster dose in certain populations.

Comirnaty

Three COVID-19 vaccines are authorized for emergency use. The vaccines are:

Pfizer BioNTech COVID-19 Vaccine

Moderna COVID-19 Vaccine

Janssen (sometimes called Johnson & Johnson) COVID-19 Vaccine

Emergency use authorization (EUA) allows these vaccines to be distributed in the U.S. Learn more about EUAs for COVID-19 vaccines from the FDAs Center for Biologics Evaluation and Research (CBER).

The FDA is the regulatory authority with oversight of the safety, effectiveness and quality of vaccines that are used in the U.S., including COVID-19 vaccines. Career scientists and doctors at the FDA determine whether to approve or authorize COVID-19 vaccines after they thoroughly analyze and evaluate the data submitted by the manufacturer related to safety, effectiveness and manufacturing quality.

During a public health emergency like the current COVID-19 pandemic, the FDA may issue an EUA when the agencys scientific experts have determined, among other things, that the known and potential benefits of the vaccine outweigh its known and potential risks.

For Comirnaty, the company submitted a Biologics License application (BLA) to FDA which built on the extensive data and information previously submitted that supported the EUA. This included preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections at the sites at which the vaccine is made.

FDA employees are also fathers, mothers, daughters, sons, sisters, brothers and more. They and their families are directly impacted by the work they do.

When you get a COVID-19 vaccine, you are choosing to protect yourself and make a difference for your children, parents, grandparents, and other loved ones. Millions of people in the U.S. have already received a COVID-19 vaccine. For a community to be fully protected, most community members need to get the vaccine. Getting vaccinated to prevent COVID-19 will help protect you from COVID-19, and it may also protect the people around you.

Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233 to find COVID-19 vaccine locations near you in the U.S. In some states, information may be limited while vaccination providers and pharmacies are being added. Contact your state health department to find additional vaccination locations in your area.

FDA-authorized or approved COVID-19 vaccines are distributed for free by states and local communities. You cannot buy COVID-19 vaccines online. You do not need to pay any out-of-pocket costs to get a COVID-19 vaccine not before, during, or after your appointment. If someone asks you to pay for your vaccine, it is either a scam or a mistake.

Yes. All FDA-approved and FDA-authorized COVID-19 vaccines prevent COVID-19 and serious health outcomes that COVID-19 can cause, including hospitalization and death. The FDA thoroughly evaluated and analyzed safety and effectiveness data for Comirnaty, the approved COVID-19 vaccine and those vaccines authorized for emergency use.

In evaluating requests for emergency use authorization for COVID-19 vaccines, the FDA determined that the available data provided clear evidence that the known and potential benefits outweigh the known and potential risks of each vaccine.

In evaluating the data and information included in the BLA for Comirnaty, the FDA determined that the vaccine is safe and effective and meets our rigorous standards for approval.

The available information suggests that the approved vaccine and the authorized vaccines protect the American public against COVID-19 caused by currently circulating strains of the virus that causes COVID-19.

Some variants are more contagious and spread more easily from person-to-person than the original virus that causes COVID-19. To help slow the spread of COVID-19, get a COVID-19 vaccine when it is available to you.

The FDA evaluated data from clinical studies that included tens of thousands of people for Comirnaty, the FDA-approved COVID-19 vaccine, and for each of the COVID-19 vaccines authorized for emergency use.

Authorized COVID-19 Vaccines

The FDA has authorized three vaccines for emergency use because the data from clinical studies clearly showed that the known and potential benefits of the FDA-authorized COVID-19 vaccines outweighed the known and potential risks.

Approved COVID-19 Vaccine

The data to support the decision to approve Comirnaty builds on extensive data and information that supported the Pfizer-BioNTech COVID-19 Vaccine EUA , including information about the vaccines safety and effectiveness. The safety of Comirnaty was evaluated in individuals 16 years of age and older, approximately 22,000 of whom received the vaccine and 22,000 of whom received placebo. More than half of the clinical trial participants were followed for safety follow-up for at least four months after the second dose. After issuance of the EUA, clinical trial participants were unblinded in a phased manner over a period of months to offer placebo recipients the Pfizer-BioNTech COVID-19 Vaccine. Overall, in blinded and unblinded follow-up, approximately 12,000 vaccine recipients have been followed for at least 6 months.

Allergic Reactions

Allergic reactions, including cases of anaphylaxis have happened after some people received a COVID-19 vaccine. Anaphylaxis is a severe, life-threatening allergic reaction that happens within seconds or minutes of exposure to an allergen. Because of this remote chance of severe allergic reaction or anaphylaxis, health care providers may ask you to stay at the place where you received your COVID-19 vaccine for monitoring for 15 to 30 minutes.

Myocarditis and Pericarditis Following Vaccination with Comirnaty, Moderna and Pfizer-BioNTech COVID-19 Vaccines

Post-authorization safety surveillance data pertaining to myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose of the Comirnaty, Moderna, and Pfizer-BioNTech COVID-19 vaccines. For each of these vaccines, the risk is higher in males under 40 years of age than in females or older males.

The Prescribing Information for Comirnaty and the Fact Sheets for Healthcare Providers Administering Vaccine (Vaccination Providers) for the Moderna and Pfizer-BioNTech COVID-19 vaccines include a warning about to the risk of myocarditis and pericarditis, and the Fact Sheet for Recipients and Caregivers includes information about myocarditis and pericarditis. The Fact Sheets for Recipients and Caregivers note that vaccine recipients should seek medical attention right away if they experience any of the following symptoms after vaccination: Chest pain Shortness of breath Feelings of having a fast-beating, fluttering, or pounding heart

Based on available information of the confirmed reported cases of myocarditis or pericarditis, most affected individuals were hospitalized and most responded well to treatment and rest, and their symptoms went away quickly.

FDA and CDC are monitoring the reports, collecting more information, and will follow-up to assess longer-term outcomes over several months.

Guillain Barr Syndrome Following Vaccination with Janssen COVID-19 Vaccine

Guillain Barr syndrome (a neurological disorder in which the bodys immune system damages nerve cells, causing muscle weakness and sometimes paralysis) has occurred in some people who have received the Janssen COVID-19 Vaccine. In most of these people, symptoms began within 42 days following receipt of the Janssen COVID-19 Vaccine. The chance of having this occur is very low. The Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) includes a warning about the suggested increased risk of Guillain Barr Syndrome (GBS) and the Fact Sheet for Recipients and Caregivers includes information about GBS. The Fact Sheet for Recipients and Caregivers notes that vaccine recipients should seek medical attention right away if they experience any of the following symptoms after receiving the Janssen COVID-19 Vaccine: Weakness or tingling sensations, especially in the legs or arms, thats worsening and spreading to other parts of the body Difficulty walking Difficulty with facial movements, including speaking, chewing, or swallowing Double vision or inability to move eyes Difficulty with bladder control or bowel function

Blood Clots in Combination with Low Blood Platelets Following Vaccination with Janssen COVID-19 Vaccine

As a result of ongoing safety monitoring, on April 13, 2021, the FDA and CDC recommended a temporary pause in the use of Janssen COVID-19 Vaccine, due to reports of a serious and rare type of blood clot in combination with low blood platelets (blood cells that help your body stop bleeding). This serious condition is called thrombosis with thrombocytopenia syndrome (TTS).

On April 23, 2021, the FDA and CDC lifted the recommended pause on the Janssen COVID-19 Vaccine after this thorough safety review. The Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) to include a warning about the risk of blood clots with low blood platelets. The warning notes that people who developed blood clots with low blood platelets after receiving the Janssen COVID-19 Vaccine, symptoms began about 1 to 2 weeks after vaccination. Reporting of these blood clots with low levels of platelets has been highest in females ages 18 through 49 years. The Fact Sheet for Recipients and Caregivers also includes information about blood clots with low blood platelets after receiving the Janssen COVID-19 Vaccine and notes that vaccine recipients should seek medical attention right away if they experience any of the following symptoms after receiving the Janssen COVID-19 Vaccine:

These may not be all the possible side effects of Janssen COVID-19 Vaccine. Serious and unexpected side effects may occur.

The FDA is publicly sharing information about COVID-19 vaccines so you can see the evidence for yourself. The FDAs analysis of clinical trial data, including but not limited to demographic information about the clinical study volunteers, is available in the Summary Basis for Regulatory Action for Comirnaty and the decision memos that explain FDAs basis for authorizing each vaccine for emergency use. In addition, for the authorized vaccines, an FDA Briefing Document for the Vaccines and Related Biological Products Advisory Committee is available, as noted below.

Yes. The FDA and the CDChave several systems in place to continually monitor COVID-19 vaccine safety. These systems, called passive surveillance and active surveillance systems, rapidly detect and investigate potential safety problems. Systems such as the Vaccine Adverse Event Reporting System (VAERS) and CDCs text-based v-safe system, which receive reports of adverse events following vaccination, are examples of passive surveillance systems. The FDAs BEST Initiativeis an example of an active surveillance system, which analyzes information occurring in millions of individuals recorded in large data systems to investigate any safety signals that are identified by VAERS or v-safe.

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Learn More About COVID-19 Vaccines From the FDA - FDA.gov

California Coronavirus Updates: Those Who Are Immunocompromised Or Over Age 65 Will Benefit The Most From Vaccine Booster  Capital Public Radio News

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California Coronavirus Updates: Those Who Are Immunocompromised Or Over Age 65 Will Benefit The Most From Vaccine Booster - Capital Public Radio News

Many of the donated doses bound for use in Africa, for example, were meant to come from the Serum Institute of India. But five months ago, the Indian government blocked the company from exporting any vaccines, ordering that the supply instead be directed to trying to stanch a raging second Covid wave in that country. (India now says it will allow exports to resume next month.)

We keep hearing, The vaccines are coming, the vaccines are coming, but three million people have died since the Pfizer vaccine was first authorized by the F.D.A., said Zain Rizvi, an expert on access to medicines with the advocacy organization Public Citizen.

Moderna and Pfizer have a direct financial interest in keeping their technology to themselves and guarding a competitive advantage not just in the sale of Covid vaccines, which are on track to bring in more than $53 billion in revenue this year, but also other potentially lucrative mRNA vaccines in development, such as one for cancer, H.I.V. and malaria, he said, adding, They dont want to stand up a future competitor.

The coalition of drugmakers in developing countries that is drafting an appeal to Mr. Biden plans to ask the U.S. government to pressure companies for several things: a license for the intellectual property, a license for the technology involved in the manufacturing of the vaccines, the provision of items such as cell lines and assistance in acquiring vital but scarce equipment.

In exchange for sharing its process, Moderna would be compensated with a licensing fee, a percentage of each dose sold.

Even without Modernas cooperation, the W.H.O. says its tech transfer hub in South Africa will focus on trying to replicate as closely as possible the Moderna formula, as the gold standard against which to compare candidates from other biotechnology companies, and then teach any manufacturer who wants to make it how to do so at scale.

If we had Moderna or BioNTech with us, we could get to an approved vaccine in 18 months, but without them we have to go through full development so its 36 months if everything goes perfectly, but it could be longer, said Dr. Friede, who heads the W.H.O.s Initiative for Vaccine Research.

Pfizer and Moderna are at a pivotal moment where they can decide what role they want to play in the process, he said. Ive made many successful vaccines; with me I have other people who have made successful vaccines, he said. What we are actually saying is: Were going to do this. So you can come in and try and maintain some control by actually producing vaccines locally, or were going to do it without you. And then youve lost control.

Rebecca Robbins contributed reporting.

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Pressure Grows on U.S. Companies to Share Covid Vaccine Technology - The New York Times

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What Is the R.1 COVID-19 Variant? Here's What We Know So Far

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What Is the R.1 COVID-19 Variant? Here's What We Know So Far - Health.com

Lanson Jones did not think that the coronavirus would come for him. An avid tennis player in Houston who had not caught so much as a cold during the pandemic, he had refused a vaccine because he worried that it would spoil his streak of good health.

But contracting Covid shattered his faith in his bodys defenses so much so that Mr. Jones, nose clogged and appetite vanished, began hunting for anything to spare himself a nightmarish illness.

The answer turned out to be monoclonal antibodies, a year-old, laboratory-created drug no less experimental than the vaccine. In a glass-walled enclosure at Houston Methodist Hospital this month, Mr. Jones, 65, became one of more than a million patients, including Donald J. Trump and Joe Rogan, to receive an antibody infusion as the virus has battered the United States.

Vaccine-resistant Americans are turning to the treatment with a zeal that has, at times, mystified their doctors, chasing down lengthy infusions after rejecting vaccines that cost one-hundredth as much. Orders have exploded so quickly this summer to 168,000 doses per week in late August, up from 27,000 in July that the Biden administration warned states this week of a dwindling national supply.

The federal government, which was already covering the cost of the treatment currently about $2,100 per dose has now taken over its distribution as well. For the coming weeks, the government has told states to expect scaled-back shipments because of the looming shortages.

With seven Southern states accounting for 70 percent of orders, the new process has unsettled some of their governors, who have made the antibody treatment central to their strategy for enduring a catastrophic wave of the Delta variant.

More supplies are on the way. The federal government bought 1.8 million more doses this week, expected to arrive in the fall and winter. But for now, some hospitals are uncertain of supplies, state health officials said, even as patients keep searching for doses.

We have providers struggling to get the necessary product, Kody Kinsley, who leads operations for North Carolinas Covid-19 response, said in an interview. I think what has happened is a classic logistics issue, where all of a sudden theres much more demand.

Amid a din of antivaccine falsehoods, monoclonal antibodies have become the rare coronavirus medicine to achieve near-universal acceptance. Championed by mainstream doctors and conservative radio hosts alike, the infusions have kept the countrys death toll 2,000 per day and climbing from soaring even higher.

And after months of work by President Biden and Southern governors to promote the treatments, they have won the affection of vaccine refusers who said that the terrors and uncertainties of actually getting Covid had made them desperate for an antidote.

The people you love, you trust, nobody said anything negative about it, Mr. Jones said of the antibody treatment. And Ive heard nothing but negative things about the side effects of the vaccine and how quickly it was developed.

Some Republican governors have set up antibody clinics while opposing vaccine mandates, frustrating even some of the drugs strongest proponents. Raising vaccination rates, scientists said, would obviate the need for many of the costly antibody treatments in the first place. The infusions take about an hour and a half, including monitoring afterward, and require constant attention from nurses whom hard-hit states often cannot spare.

Its clogging up resources, its hard to give, and a vaccine is $20 and could prevent almost all of that, said Dr. Christian Ramers, an infectious disease specialist and the chief of population health at Family Health Centers of San Diego, a community-based provider. Pushing antibodies while playing down vaccines, he said, was like investing in car insurance without investing in brakes.

The government-supplied monoclonal antibodies, made by Regeneron and Eli Lilly, have been shown to significantly shorten patients symptoms and reduce their risk of being hospitalized by 70 percent, in the case of Regenerons antibody cocktail. The treatments, given in a single sitting, use lab-made copies of the antibodies that people generate naturally when fighting an infection.

Patients and doctors alike overlooked the treatments during the wintertime surge of infections. But hospitals and health centers have now ramped up their offerings, transforming dental clinics, mobile units and auditoriums into infusion centers. In states like Texas, where elective surgeries have been postponed to make room for Covid-19 patients, operating room nurses have been enlisted to give infusions.

One factor driving the demand is that many patients, including vaccine skeptics, have been spreading the word about their seemingly miraculous recoveries.

Sept. 19, 2021, 3:43 p.m. ET

Theyre like, I have Covid, I want this treatment, my friend or family told me about this, said Jennifer Berry, the Houston Methodist nursing director of infusion services. Now the word is out.

At Houston Methodist, nurses administered nearly 1,100 treatments across eight sites in the first week of September, well more than twice as many as any week last winter. The hospital reduced the average time between orders and infusions to two days this month from three days in early August, giving patients a better chance of fighting off infections.

Juggling the infusions with more seriously ill Covid patients this summer forced the hospital, in one case, to move a monoclonal antibody clinic to a strip mall storefront.

But the Texas health department has helped, providing 19 nurses for a different Houston Methodist infusion clinic, said Vicki Brownewell, the lead administrator for the hospitals program. The Biden administration has also invested $150 million in expanding access to monoclonal antibodies, and Houston Methodist has used federal money to arrange medical taxis for patients struggling with transportation.

Even so, the infusions remain inaccessible to many. Given the heavy demands on staff and the need to create separate infusion rooms for infectious patients, certain communities, especially in rural areas, do not have clinics.

In San Diego, Dr. Ramers said, some large, for-profit hospitals have decided not to administer the antibodies at all because of the logistical hassles, leaving wealthier, well-insured patients to hunt down doses at his publicly funded clinic. Some nurses that he hired for infusions left for short, better-paying assignments in hard-hit intensive care units.

The natural, capitalist incentives for health care organizations that are for profit dont really favor doing this, Dr. Ramers said. Its a lot of work.

UnderstandVaccine and Mask Mandates in the U.S.

Of the 2.4 million monoclonal antibody doses shipped nationally, at least 1.1 million have been used. Precisely how many are still sitting on shelves is hard to determine because of reporting gaps. Still, waning federal supplies and soaring demand from less-vaccinated Southern states have caused what several states have described as large shortfalls in deliveries.

North Carolina providers have requested 15,000 weekly doses, the health department there said, more than double what the federal government has allocated. Florida said its latest weekly allotment left clinics there 41,000 doses short of what they wanted.

Hospitals had previously been able to order the drugs themselves. But the Department of Health and Human Services will now decide how many doses each state receives based on case rates and use of the treatment. State governments, in turn, will decide on doses for individual sites.

The new ordering process, which the Biden administration said would ensure equitable distribution, has unsettled some backers of the drug. Gov. Ron DeSantis of Florida, a Republican, warned on Thursday that state officials were unprepared for the new responsibility of parceling out doses.

And in heavily vaccinated states, like New York, people coordinating treatments fear that shipments will plummet because of low case rates, leaving hospitals with so few doses that they shutter their programs. Some hospitals recently reported growing numbers of vaccinated patients receiving infusions.

Diana Berrent, the founder of Survivor Corps, which has worked to help patients find monoclonal antibody treatments, said that involving state governments would create delays: Youre layering in 50 new layers of bureaucracy, she said.

Doctors have warned that antibody treatments alone cannot keep pace with ballooning outbreaks. Whereas any one vaccination protects untold others from exposure, a single infusion only helps a single patient. Infusions must be given within 10 days of symptoms; they are unhelpful to most hospitalized patients. And receiving the antibodies once does not keep people from becoming seriously ill if they catch the virus again later.

Something like that just doesnt scale, said Dr. Howard Huang, the medical leader for Houston Methodists infusion program.

As a result, health officials have warned that vaccine skeptics may become so enamored of monoclonal antibodies that they become even more resistant to getting a protective shot.

Within days of his infusion, Mr. Jones, the patient in Houston, had left the bedroom where he had been quarantined and returned to his work as a landscape architect. But he was still weighing whether to be vaccinated.

His doctor was pushing for the shot, he said. But the monoclonal antibodies had worked so well that he was tempted to simply return for another infusion if he caught Covid-19 again.

If I can go get an infusion and feel as good as I do right now, man, Id rather not take a vaccine that has just been developed, he said. That makes me nervous, still.

Rebecca Robbins contributed reporting.

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They Shunned Covid Vaccines but Embraced Antibody Treatment - The New York Times

Advisers to the Food and Drug Administration on Friday questioned a key assertion by researchers in Israel and by the drug company Pfizer: that its coronavirus vaccine is waning in protection not just against infection, but against severe illness and hospitalization.

The advisers met to evaluate Pfizers application for approval of booster vaccine doses for all Americans over age 16. Among the details that surfaced during the lively debate: Israel and the United States define severe illness differently.

In Israel, anyone with an accelerated respiratory rate and an oxygen level of below 94 percent is severely ill. By contrast, the Centers for Disease Control and Prevention considers people who are sick enough to be hospitalized as having severe disease, Dr. Sara Oliver, a C.D.C. scientist, said at the advisory committee meeting.

The discrepancy might help explain why the two countries have reported vastly different outcomes in people who are fully immunized.

Israeli researchers said they have seen large numbers of hospitalized patients who had received two doses months earlier. But in the United States, the C.D.C. has reported that vaccinated patients make up just 2 percent of people hospitalized for Covid-19.

It is just one of many scientific discrepancies that came to light this week.

On Monday, in the journal The Lancet, an international team of scientists analyzed dozens of studies and concluded that boosters are not yet needed by the general population, and that the world would be better served by using vaccine doses to protect the billions of people who remain unvaccinated.

On Wednesday, scientists at the F.D.A. posted an assessment online hinting that they, too, are unconvinced that theres enough evidence that boosters are needed.

Overall, data indicate that currently U.S.-licensed or authorized Covid-19 vaccines still afford protection against severe Covid-19 disease and death in the United States, according to their executive summary.

But some F.D.A. leaders have publicly endorsed booster shots. The need for an additional dose at six months to provide longer-term protection should not come as a surprise, as its likely necessary for the generation of a mature for immune response, Dr. Peter Marks, one of the agencys top officials, said in the meeting on Friday.

Alarmed by the rise in cases, Israeli officials have offered third doses of the vaccine to everyone older than 12. Researchers from Israel published early results from that rollout on Wednesday in the New England Journal of Medicine but few outside scientists found the study convincing.

UnderstandVaccine and Mask Mandates in the U.S.

The team collected data on the effects of booster shots from the health records of more than 1.1 million people over age 60. At least 12 days after the booster, rates of infection were elevenfold lower and rates of severe disease nearly twentyfold lower in those who received a booster compared with those who had received only two doses, the researchers found.

The results are unsurprising, experts said, and do not indicate long-term benefit.

We have known for some time that the vaccines elicit less robust immune responses in the elderly, said Dr. Celine Gounder, an infectious disease specialist at Bellevue Hospital Center and a former adviser to the Biden administration. Recommending additional doses of vaccine for the elderly isnt controversial.

Vaccination remains powerfully protective against severe illness and hospitalization in the vast majority of people in all of the studies published so far, experts said. But the vaccines do seem less potent against infections in people of all ages, particularly those exposed to the highly contagious Delta variant.

The cumulative data so far suggest that only older adults will need boosters, a view underscored by the F.D.A.s advisory committee, which voted on Friday to endorse boosters only for Americans aged 65 and older, and those who are at risk for severe illness.

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Research on Covid Booster Shots is Conflicting - The New York Times

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