Tag: Pfizer

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Pfizer begins trial on infants and younger youngsters

U.S. ‘flying blindly’ when it comes to new Covid variant, says doctor

A healthcare worker prepares a vaccination for Pfizer coronavirus disease (COVID-19) in Los Angeles, California on January 7, 2021.

Lucy Nicholson | Reuters

Pfizer announced that it has started a clinical trial testing the Covid-19 vaccine in healthy children aged 6 months to 11 years. This is a critical step in gaining regulatory approval to vaccinate young children and fight the pandemic.

The first participants in the study have already made their recordings, which were developed in collaboration with the German drug manufacturer BioNTech, New York-based Pfizer announced on Thursday. In the first phase, 144 children are to be enrolled.

In the first phase of the study, the company will determine the preferred dosage level for three age groups – between 6 months and 2 years, 2 and 5 years, and between 5 and 11 years. The children will first receive a dose of 10 micrograms of the vaccine before gradually moving on to higher doses, Pfizer said. Participants also have the option of ingesting 3 micrograms doses. The adult Covid vaccine requires two shots that contain 30 micrograms per dose.

Researchers will then evaluate the safety and effectiveness of the selected dose levels in the next phase of the study, with participants being randomly selected to receive the vaccine or a placebo, the company said. After a six-month follow-up visit, children who received a placebo will have the option to receive the vaccine.

“Pfizer has extensive experience developing clinical trials of vaccines in children and infants and is committed to improving the health and well-being of children through well-designed clinical trials,” the company said in a statement.

Pfizer’s vaccine has already been approved for use in the United States by Americans 16 and older. Clinical studies testing the vaccine in children whose immune systems may react differently than adults are still to be completed.

Vaccinating children is critical to ending the pandemic, say public health officials and infectious disease experts. The US is unlikely to achieve herd immunity – or if enough people in a given community have antibodies to a given disease – before children can be vaccinated. According to the government, children make up around 20% of the US population.

In late January, Pfizer announced that it had fully registered the Covid-19 vaccine study for children ages 12-15. The company announced Thursday that the data in this cohort was “encouraged” and hopes to provide more details about the study. soon.”

Moderna, which also has a US-approved vaccine, announced on March 16 that it has started testing its shot in children under the age of 12. Moderna started a study in December testing children aged 12 to 17 years.

Johnson & Johnson plans to test its single-shot vaccine in infants and even newborns after it was first tested in older children, according to the New York Times.

The Chief Medical Officer of the White House, Dr. Anthony Fauci, speaking to a House committee earlier this month, said the U.S. could vaccinate older children against Covid-19 starting this fall, while elementary school-age children may get their shots early next year.

Pfizer’s announcement comes two days after the start of an early-stage clinical trial of an experimental oral antiviral drug that could be used at the first sign of Covid infection.

Health experts say the world will still need a slew of drugs and vaccines to end the pandemic that has infected more than 30 million Americans and killed at least 545,282 people in just over a year, according to Johns Hopkins University.

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Pfizer begins early stage scientific trial testing oral antiviral drug

Pfizer begins early stage clinical trial testing oral antiviral drug

Pfizer said Tuesday it had started an early clinical trial of an experimental oral antiviral drug for Covid-19.

The New York-based company announced that the Phase 1 study of the drug PF-07321332 will be conducted in the United States. The drug belongs to a class of drugs called protease inhibitors, and it works by blocking an enzyme that the virus needs to replicate in human cells.

Protease inhibitors are used to treat other viral pathogens such as HIV and hepatitis C.

“Fighting the COVID-19 pandemic requires both preventive vaccination and targeted treatment of those who become infected with the virus,” Pfizer’s chief scientist Mikael Dolsten said in a press release. “Given the way SARS-CoV-2 is mutating and the ongoing global impact of COVID-19, it is likely that access to therapeutic options will be critical both now and after the pandemic.”

The study comes as Pfizer is also working on an intravenously administered protease inhibitor known as PF-07304814. This drug is currently in a Phase 1b clinical trial in patients hospitalized with Covid-19.

A person walks past the Pfizer building in New York City on March 2, 2021.

Carlo Allegri | Reuters

Pfizer already has an approved vaccine in the US with German drug maker BioNTech, but health experts say the world will need a slew of drugs and vaccines to end the pandemic that is infecting more than 29.8 million Americans and is coming soon Has killed at least 542,991 people over a year, according to the Johns Hopkins University.

Preclinical studies have shown that the oral drug, the first orally ingested protease inhibitor for Covid-19 to be studied in clinical trials, has “strong” antiviral activity against the virus.

Because the drug is taken orally, it can be used outside of hospitals for people newly infected with the virus. The researchers hope the drugs will prevent the disease from getting worse and keep people out of the hospital.

Pfizer said it will provide more details on the drug at the Spring American Chemical Society meeting on April 6.

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Detroit mayor rejects preliminary J&J vaccine cargo, calls Pfizer, Moderna ‘the very best’

Detroit mayor rejects initial J&J vaccine shipment, calls Pfizer, Moderna 'the best'

Vial of the Janssen Coronavirus Disease (COVID-19) vaccine from Johnson & Johnson

Johnson & Johnson via Reuters

Detroit Mayor Mike Duggan turned down an initial allocation of the Johnson & Johnson Covid-19 single vaccine this week, according to the Michigan State Department of Health.

At a news conference Thursday, Duggan confirmed that he had refused to grant J&J vaccines from the state this week, citing sufficient supply of Pfizer and Moderna vaccines to meet demand from eligible residents.

“Johnson & Johnson is a very good vaccine. Moderna and Pfizer are the best. And I’ll do everything I can to make sure the Detroit city residents get the best,” Duggan said at a news conference Thursday.

The FDA on Saturday approved J & J’s Covid-19 vaccine for emergency use. This makes it the third vaccine approved for distribution in the United States and the only vaccine that requires only one dose.

Clinical trial data shows that J & J’s vaccine provides 66% overall protection against Covid, compared to around 95% for Pfizer and Moderna vaccines. While some have raised concerns about the J&J vaccine’s lower rate of effectiveness, the J&J vaccine has been shown to prevent 100% of virus-related hospitalizations and deaths, according to clinical trial data.

“All vaccines are safe and effective, and I recommend that all vaccines be offered in all communities,” said Dr. Michigan chief medical executive Joneigh Khaldun in a statement to CNBC.

“Also, the Johnson and Johnson vaccine has been studied in a more recent period of time with more easily transmissible variants, so I would not recommend comparing the Pfizer and Moderna studies directly with the Johnson and Johnson studies,” Khaldun said.

At a news conference on Friday, Andy Slavitt, Senior White House Covid Advisor, said Duggan’s comments on the J&J vaccine had been misunderstood.

“We have had a constant dialogue with Mayor Duggan … He is very excited about the Johnson & Johnson vaccine. And I think we want to reiterate the message that the very first vaccine we can take makes perfect sense for all of us is take, “said Slavitt.

In a statement later Friday, Duggan reiterated the effectiveness of the J&J shot in preventing hospitalizations and Covid-related deaths.

“The only reason we decided not to take the first shipment from Johnson & Johnson was because we had the capacity with Moderna and Pfizer to handle the 29,000 first and second dose appointments planned for the coming week which has already brought us very close to our capacity at our current locations, “Duggan said in a statement on Friday.

The J&J allotment, rejected by Duggan, comprised 6,200 doses that were distributed to other local Michigan health departments, according to Bob Wheaton, spokesman for the state health department.

Wheaton said the state doesn’t expect to receive any more J&J vaccines “for a few weeks.”

Duggan said the city will open a new vaccination site for J&J shots if demand from eligible residents exceeds supply of Moderna and Pfizer cans.

“We always planned to distribute Johnson & Johnson as soon as demand warranted it, and we had our distribution plan so we could make it available to our residents as much as Moderna and Pfizer,” Duggan said in Friday’s statement. “By the time the next J&J broadcast arrives, we’ll have our plan to make it available.”

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Right here is How Johnson & Johnson’s Vaccine Differs from Pfizer and Moderna’s

Here is How Johnson & Johnson's Vaccine Differs from Pfizer and Moderna's

A third effective weapon was added to the American arsenal against the coronavirus on Saturday when the Food and Drug Administration granted emergency approval for a vaccine developed by Johnson & Johnson.

The company announced it would begin shipping millions of cans earlier this week and ship 100 million cans to the US by the end of June. Together with 600 million doses of the country’s first two approved vaccines, manufactured by Pfizer-BioNTech and Moderna, due to be dispensed over the next four months, that should be enough to cover every American adult who wants to be vaccinated.

The new vaccine is very different from the two already used in the US. Here’s how they compare.

The Johnson & Johnson vaccine is given in one shot, while the Pfizer BioNTech and Moderna vaccines are given in two shots several weeks apart.

The Johnson & Johnson vaccine uses a different method to prepare the body to fight Covid-19: a viral vector called Ad26. Viral vectors are common viruses that have been genetically modified so that they do not cause disease, but can still cause the immune system to build up its defenses. The vaccines Pfizer-BioNTech and Moderna use messenger RNA for this.

The Johnson & Johnson vaccine is found to be highly effective in preventing serious illness and death, as are Pfizer-BioNTech and Moderna vaccines. It’s also very effective in preventing milder diseases, albeit a little less than either of these. It appears to be good against the highly contagious variant B.1.351, which was first identified in South Africa and has caused problems at least one other vaccine candidate.

The Johnson & Johnson vaccine does not need to be stored at extremely low temperatures like the Pfizer BioNTech vaccine. It can be safely stored in a regular refrigerator for three months, much longer than the Moderna vaccine, which spoils after a month if left frozen.

The Johnson & Johnson vaccine appears to be less susceptible than the Pfizer-BioNTech and Moderna vaccines to causing the types of side effects that need to be monitored after injection, which may make it more suitable for drive-through vaccination site use. It has been reported that side effects tend to be more felt after second doses that the Johnson & Johnson vaccine doesn’t need.

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Biden speaks at Pfizer vaccine manufacturing website as storm delays shipments

Biden speaks at Pfizer vaccine manufacturing site as storm delays shipments

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President Joe Biden speaks at Pfizer’s Covid-19 vaccine factory in Kalamazoo, Michigan on Friday as his government works to increase the supply of doses in the U.S.

Earlier in the day, government officials said the massive winter storms in the Midwest and Texas had delayed delivery of 6 million Covid-19 vaccine doses this week, affecting every state in the US. The backlog equates to three days of late deliveries, Andy Slavitt, Senior White House Advisor on Covid Response, said during a news conference.

Slavitt also announced that the government is working with Florida and Pennsylvania to open five more vaccination centers.

Four of the five vaccination centers will be located in the cities of Jacksonville, Miami, Orlando and Tampa, Florida. The four sites could vaccinate up to 12,000 people a day. A fifth center in Philadelphia will be able to vaccinate 6,000 people a day, he said.

Read CNBC’s live updates for the latest news on the Covid-19 outbreak.

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Pfizer asks FDA to approve storing doses at greater temperatures

Pfizer to temporarily reduce Covid vaccine deliveries to Europe

A picture taken on January 15, 2021 shows a pharmacist holding a vial of undiluted Pfizer BioNTech vaccine for Covid-19 with gloved hands, which is stored at -70 ° in a super freezer at Le Mans hospital in northwestern France became country runs a vaccination campaign to fight the spread of the novel coronavirus.

Jean-Francois Monier | AFP | Getty Images

Pfizer is asking the Food and Drug Administration for permission to store its Covid-19 vaccine for two weeks at temperatures typically found in pharmaceutical freezers and refrigerators, the US drug maker said on Friday.

The vaccine, which was developed with the German drug manufacturer BioNTech, currently has to be stored in ultra-cold freezers, which, according to the FDA, are between minus 112 and minus 76 degrees Fahrenheit. Pfizer said it presented new data to the U.S. agency showing the vaccine is stable between negative 13 and 5 degrees Fahrenheit.

If the FDA grants the OK, it could simplify the logistics for distributing the vaccine in the US. Federal and state officials are trying to speed up the pace of vaccinations across the country as the virus continues to spread.

“We have continuously conducted stability studies to support the manufacture of the vaccine on a commercial scale with the aim of making the vaccine as accessible as possible to healthcare providers and people in the US and around the world,” said Albert Bourla, CEO of Pfizer a publication. “If approved, this new storage option would offer pharmacies and vaccination centers more flexibility in managing their vaccine supplies.”

Medical experts had previously warned that Pfizer’s vaccine would pose a new logistical challenge as it would have to be stored in ultra-cold temperatures. In December, US officials said they quarantined several thousand doses of the vaccine in California and Alabama after an “anomaly” in the transportation process caused the storage temperature to become too cold.

The vaccine comes in a special warming container that can be used as a temporary storage facility for up to 30 days, with dry ice refilled every five days. The vaccine can also be refrigerated for up to five days at a standard refrigerator temperature of between 36 and 46 degrees Fahrenheit, according to the company, before mixing it with a salt diluent.

In comparison, Moderna’s vaccine has to be delivered between 13 and 5 degrees Fahrenheit. It has said its vaccine will stay stable for up to 30 days at 36 to 46 degrees Fahrenheit, the temperature of a regular household or medical refrigerator. It can be stored at minus 4 degrees Fahrenheit for up to six months.

Johnson & Johnson’s Covid vaccine, expected to receive FDA emergency approval as early as this month, plans to ship its vaccine at 36 to 46 degrees Fahrenheit.

As additional stability data will be obtained, Pfizer believes that shelf life could be extended and alternative short term temperature storage could be considered.

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Pfizer PFE This autumn 2020 earnings fall brief, however income beats expectations

Pfizer PFE Q4 2020 earnings fall short, but revenue beats expectations

Pfizer said Tuesday it expects to sell about $ 15 billion in coronavirus vaccine doses this year and make a profit on the high 20% sales margin for the vaccinations.

At the time of its fourth quarter earnings release, Pfizer was forecasting revenue of between $ 59.4 billion and $ 61.4 billion for this year and anticipating high pre-tax adjusted earnings of 20% for the vaccine.

The company also raised its full-year earnings guidance from $ 3.10 to $ 3.10-3.20, citing “additional improvements” to its guidance for vaccine sales.

According to Refinitiv’s average estimates, Pfizer performed in the fourth quarter compared to Wall Street expectations.

  • Adjusted EPS: 42 cents compared to 48 cents expected.
  • Revenue: $ 11.68 billion versus $ 11.43 billion expected.

Revenue rose 12% from $ 10.44 billion in the same quarter last year to $ 11.68 billion – better than analysts expected.

Pfizer shares were down 2.8% in midday trading.

“As a company, we have seen the culmination of Pfizer’s decades of transformation into a pure science and innovation-driven company,” said CEO Albert Bourla in a press release. “Our ability to move forward quickly and use the latest scientific knowledge to address the world’s major medical challenges has been tested by the COVID-19 pandemic.”

The company’s Covid-19 vaccine, which it makes together with German partner BioNTech, was the first to be approved for emergency use in the United States

Pfizer, like other Covid vaccine manufacturers, is struggling to meet demand for shots which, hopefully, will help end the pandemic. Recently, the French pharmaceutical company Sanofi was asked for help with making cans.

In slides released ahead of the earnings call, Pfizer plans to ship 200 million doses of its coronavirus vaccine to the U.S. by May, earlier than originally forecast in July.

The company also said it could potentially deliver 2 billion doses globally by the end of this year, as healthcare providers can extract an additional sixth dose of the vaccine from the vials. In December, the Food and Drug Administration announced that additional doses from vials could be used after the cans were discarded due to labeling confusion.

The company also said Tuesday it would be “ready to respond” if a variant of Covid shows evidence of bypassing its vaccine. In the past few weeks, U.S. health officials, including Dr. Anthony Fauci, raised concerns that vaccines currently on the market may not be as effective against new, more contagious strains of the virus.

Novavax said Thursday its vaccine was only 49% effective against B.1.351, the highly contagious strain in South Africa. Johnson & Johnson also said its vaccine was less effective against the strain. On Friday, his one-time vaccine was 66% effective overall, but only 57% in South Africa.

A study conducted by Pfizer found that the new, highly contagious strains in the UK and South Africa had little impact on the effectiveness of the vaccine. Nevertheless, Pfizer is developing a booster shot to protect itself from the new variants. Moderna and Novavax are also developing modified vaccines.

In the slides, Pfizer said that patients “likely need regular boosting to maintain the immune response and counter newly emerging variant strains.”

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Pfizer sending fewer Covid vaccine vials to account for additional doses

Pfizer sending fewer Covid vaccine vials to account for extra doses

Dr. Scott Gottlieb, who sits on Pfizer’s board of directors, on Monday defended the company’s move to send fewer vials of its Covid-19 vaccine and count six doses per vial instead of five. This is the best way to ensure the extra dose is used.

When the company started shipping vaccine bottles last month, pharmacists found that they could often extract an extra dose from each vial, which on paper only held five doses. That discovery meant the United States could actually receive more doses of the vaccine than the $ 200 million the Department of Defense bought under its deal with Pfizer.

“The bottom line is that this is a very scarce resource. We have to make sure that every dose is used,” Gottlieb said Monday in CNBC’s “Squawk Box”. “The only way to do this is to market this as a six-dose vial and have the right equipment ready to extract that sixth dose, which is what Pfizer is actually doing.”

The New York Times reported Friday that Pfizer executives in recent weeks have successfully urged Food and Drug Administration officials to revise the wording of the vaccine’s emergency approval to officially include the sixth dose for the federal treaty.

Some pharmacists were confused by the extra doses or didn’t have the correct syringes to extract them and threw them away.

“During this pandemic that is killing many people around the world, it is important that we use all available vaccines and vaccinate as many people as possible. To keep an extra dose in each vial that could be used to vaccinate more people would be one Tragedy, “said company spokeswoman Amy Rose.

Gottlieb said Monday the move will help the US speed up the distribution of vaccine doses, adding that Pfizer can now deliver 120 million doses of the vaccine in the first quarter of 2021, up from 100 million before the labeling change.

However, the move puts pressure on U.S. pharmacists to extract six doses from each vial, which requires some special syringes called low dead space syringes. The US government, which ships kits of syringes and vaccine doses, has signed a contract with syringe manufacturers such as Becton Dickinson, the world’s largest syringe maker, to ensure supplies to local authorities.

However, Becton Dickinson is unable to significantly increase the US supply of syringes, Reuters reported earlier Monday, doubting how many vials the US can extract six doses from.

Gottlieb said the vaccines will only qualify as six-dose vials, which will also give local authorities the correct syringes to extract the final dose.

Gottlieb noted that when Pfizer applied for approval of his emergency vaccine, he knew that six doses could be taken from each vial, but revising the wording of the application would have delayed approval of the vaccine. The company therefore applied for approval with the intention of revising the wording later to reflect the six-dose vials.

He added that it took the U.S. FDA longer than regulators in other countries to make the change. Authorities in the UK, Switzerland and Israel have already revised the wording of their approvals for the Pfizer vaccine to take into account that each vial contains six doses.

Gottlieb, the former head of the FDA, clarified that the change should not be applied retrospectively, which means that all vials previously shipped will be counted as containing five doses.

But “at some point you had to set up the accommodation to properly account for the doses,” said Gottlieb.

Disclosure: Scott Gottlieb is a CNBC employee and a member of the boards of directors of Pfizer, genetic testing startup Tempus, health technology company Aetion Inc., and biotech company Illumina. He is also co-chair of the Healthy Sail Panel of Norwegian Cruise Line Holdings and Royal Caribbean.

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Pfizer CEO joins World Well being Group at press convention on the coronavirus outbreak

Pfizer CEO joins World Health Organization at press conference on the coronavirus outbreak

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World Health Organization officials are holding a press conference on Friday to inform the public about the coronavirus outbreak, which has infected more than 97.6 million people worldwide.

Albert Bourla, CEO of Pfizer, which makes one of the Covid-19 vaccines approved in the US and Europe, is expected to work with WHO representatives during the virtual meeting. Dr. Seth Berkley, CEO of the Gavi public-private vaccination partnership, and Henrietta Fore, Executive Director of UNICEF, will also attend the briefing.

Earlier this week, WHO Director General Tedros Adhanom Ghebreyesus warned that the world would be on the verge of “catastrophic moral failure” if it did not fairly distribute available doses of Covid-19 vaccines around the world. He added that the discovery of several transmissible strains of the virus in different parts of the world increases the urgency of the vaccine’s introduction.

“It is not right for younger, healthier adults in rich countries to be vaccinated in front of health workers and older people in poorer countries,” he said on Monday. “There will be enough vaccine for everyone, but right now we need to work together as a global family to set priorities [those] most at risk of serious illness and death in all countries. “

Last year, WHO, in collaboration with Gavi and the Coalition for Epidemic Preparedness Innovations, set up the COVAX facility to ensure equitable access to vaccines for every country in the world. By the end of 2021, 2 billion doses of safe and effective vaccines are expected to be administered.

Read CNBC’s live updates for the latest news on the Covid-19 outbreak.

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Pfizer to provide as much as 40 million Covid vaccine doses to Covax international program

Pfizer to supply up to 40 million Covid vaccine doses to Covax global program

A nurse prepares the Pfizer BioNTech Covid-19 vaccine on January 10, 2021 at a vaccination center in Sarcelles near Paris.

ALAIN JOCARD | AFP | Getty Images

Pfizer will deliver up to 40 million doses of its coronavirus vaccine to a global alliance that aims to provide coronavirus vaccines to poor nations, the head of the World Health Organization said on Friday.

The agreement will enable Covax – together with the WHO – to deliver vaccine doses to the participating countries from February, said WHO Director General Tedros Adhanom Ghebreyesus during a press conference. Tedros added that until an emergency is approved, the program expects 150 million doses of AstraZeneca’s vaccine to be available for distribution in the first quarter of this year.

The Covax program aims to provide 2 billion doses of Covid-19 vaccines to participating countries, which include low- to middle-income countries, by the end of this year. The Pfizer BioNTech vaccine requires two vaccinations spaced weeks apart, suggesting the deal would only cover 20 million people.

Tedros said the deal would allow other countries with supplies of Pfizer’s vaccine to donate them to the program. The WHO chief criticized wealthy nations for signing supply agreements with drug manufacturers for their starting doses of Covid-19 vaccines to stockpile supplies from poorer nations.

“This is not only important for COVAX, it is also an important step forward for equitable access to vaccines and an essential part of the global effort to fight this pandemic. We will only be safe everywhere if we are safe everywhere,” so Dr. Seth Berkley, CEO of Gavi, the Vaccine Alliance, said in a statement.

Albert Bourla, CEO of Pfizer, said during the press conference that the company will make the vaccine doses available to Covax and poorer countries for a fee. Pfizer was the first company to receive a global list of emergency uses for its vaccine from the WHO, allowing other countries to expedite their regulatory approval processes to begin administering the vaccine.

Bourla said the company will help ship the cans, which require ultra-cold storage and special handling, to low-income countries. UNICEF, which is helping with the dispensing of the cans, previously warned that some of the world’s poorest countries could face the challenge of storing and managing the shots upon arrival.

The program’s contract with Pfizer increases supply agreements to a total of just over 2 billion doses, but negotiations for an additional supply continue. The goal, according to Covax, is to immunize healthcare and other frontline workers as well as some high-risk individuals from the first quarter of this year.

The agreement follows the United States’ decision to remain a member of WHO under President Joe Biden. The new administration will also join the Covax program, a move the Trump administration opposed last year.

“I couldn’t escape the temptation to say that I’m very happy that this press conference is taking place on the day the United States rejoins the WHO organization. I think it’s a symbolic, great day for us,” Pfizer boss Bourla said at the meeting.