Tag: Pfizer vaccine

COVID vaccine & drug sales help Pfizer sail past forecasts, boost Q1 profit 61%

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Sales of Pfizer’s COVID-19 vaccine and treatment pushed the drugmaker well past expectations in the first quarter, as profit grew 61 percent. The coronavirus vaccine, Comirnaty, brought in more than $13 billion in sales, and the treatment Paxlovid added another $1.5 billion as company revenue swelled 77 percent, the company said on Tuesday.

Also read: IIT Madras study backs Pfizer’s Indomethacin as a more effective anti-COVID drug than paracetamol

Pfizer posted adjusted earnings of $1.62 per share in the first quarter, on $25.66 billion in revenue. Analysts expected per-share earnings of $1.49 on about $24.1 billion in sales, according to FactSet.

Also read: Pfizer offers voluntary retirement scheme for field staff

Pfizer Inc, based in New York, also revised its 2022 earnings forecast to reflect an accounting policy change. It now expects adjusted earnings of $6.25-6.45 per share. That’s down from its previous forecast for $6.35-6.55 per share.

Analysts forecast earnings of $7.14 per share. Shares ticked slightly higher before the opening bell on Thursday. 

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Omicron: Man who got three COVID-19 shots tests positive for variant

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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A 29-year-old man who had arrived in Mumbai from New York tested positive for the Omicron variant of COVID-19 on Friday, the Brihanmumbai Municipal Corporation (BMC) said in a release. Notably, the man, who has no symptoms, had taken three doses of Pfizer’s coronavirus vaccine, it added.

He tested positive for COVID-19 in a test conducted at the airport on November 9, after which his samples were sent for genome sequencing. Two of his high-risk contacts tested negative for coronavirus, BMC said.

Also read: India’s Omicron tally rises to 101; Centre urges people to avoid unnecessary travel, mass gatherings

“The patient has been admitted to a hospital as a precautionary measure and he has no symptoms,” the civic body said in a release. This raised the tally of Omicron patients found in the country’s financial capital to 15, including five who are from outside Mumbai.

But 13 of these patients have already been discharged from hospitals. In fact, none of the 15 Omicron patients found in the city so far has reported severe symptoms, the BMC said.

Also read: WHO gives emergency use nod to Serum Institute’s Covovax

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Omicron threat: US allows Pfizer booster for 16- and 17-year-olds

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The United States’ Food and Drug Administration (FDA) is expanding COVID-19 boosters, ruling that 16- and 17-year-olds can get a third dose of Pfizer’s vaccine.

The US and many other nations already were urging adults to get booster shots to pump up immunity that can wane months after vaccination, calls that intensified with the discovery of the worrisome new Omicron variant.

On Thursday, the Food and Drug Administration gave emergency authorisation for 16- and 17-year-olds to get a third dose of the vaccine made by Pfizer and its partner BioNTech — if its been six months since their last shot.

Also read: Countries weigh need for booster COVID-19 shots amid Omicron scare

There’s one more step: The Centers for Disease Control and Prevention must formally recommend the boosters for this age group and a decision is expected soon.

The Pfizer vaccine is the only option in the US for anyone younger than 18, either for initial vaccination or for use as a booster. Its not yet clear if or when teens younger than 16 might need a third Pfizer dose.

Vaccinations for children as young as 5 years old just began last month, using special low-dose Pfizer shots. By this week, about 5 million 5-to-11-year-olds had gotten a first dose.

Also read: BioNTech, Pfizer data suggests boosters may protect against Omicron infection

The extra-contagious delta variant is causing nearly all COVID-19 infections in the US, and in much of the world. Its not yet clear how vaccines will hold up against the new and markedly different Omicron mutant. But there’s strong evidence that boosters offer a jump in protection against delta-caused infections, currently the biggest threat.

Complicating the decision to extend boosters to 16- and 17-year-olds is that the Pfizer shot — and a similar vaccine made by Moderna — have been linked to a rare side effect. Called myocarditis, its a type of heart inflammation seen mostly in younger men and teen boys.

Health officials in Israel, which already gives boosters to teens, have said the side effect continues to be rare with third doses.

A U.S. study this week offered additional reassurance. Researchers from children’s hospitals around the country checked medical records and found the rare side effect usually is mild and people recover quickly, while COVID-19 itself can cause more serious heart inflammation. The research was published Monday in the journal Circulation.

Also read: COVID-19: Must learn to live with viruses; concerned about ethics of booster shots, says Dr Mathew Varghese

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Pfizer says antiviral pill cuts risk of severe COVID-19 by 89%

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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A trial of Pfizer Inc’s experimental antiviral pill for COVID-19 was stopped early after the drug was shown to cut by 89 percent the chances of hospitalization or death for adults at risk of developing severe disease, the company said on Friday.

The results appear to surpass those seen with Merck & Co Inc’s pill molnupiravir, which was shown last month to halve the likelihood of dying or being hospitalized for COVID-19 patients also at high risk of serious illness.

Full trial data is not yet available from either company.

Pfizer said it plans to submit interim trial results for its pill, which is given in combination with an older antiviral called ritonavir, to the U.S. Food and Drug Administration as part of the emergency use application it opened in October.

The combination treatment, which will have the brand name Paxlovid, consists of three pills given twice daily.

The planned analysis of 1,219 patients in Pfizer’s study looked at hospitalizations or deaths among people diagnosed with mild to moderate COVID-19 with at least one risk factor for developing severe disease, such as obesity or older age.

It found that 0.8 percent of those given Pfizer’s drug within three days of symptom onset were hospitalized and none had died by 28 days after treatment. That compared with a hospitalization rate of 7 percent for placebo patients. There were also seven deaths in the placebo group.

Also Read: US FDA clears Pfizer’s COVID-19 vaccine for children

Rates were similar for patients treated within five days of symptoms – 1 percent of the treatment group was hospitalized, compared with 6.7 percent for the placebo group, which included 10 deaths.

Antivirals need to be given as early as possible, before an infection takes hold, in order to be most effective. Merck tested its drug within five days of symptom onset.

“We saw that we did have high efficacy, even if it was five days after a patient has been treated … people might wait a couple of days before getting a test or something, and this means that we have time to treat people and really provide a benefit from a public health perspective,” Annaliesa Anderson, head of the Pfizer program, told Reuters.

The company did not detail side effects of the treatment, but said adverse events happened in about 20 percent of both treatment and placebo patients.

“These data suggest that our oral antiviral candidate, if approved by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations,” Pfizer Chief Executive Albert Bourla said in a statement.

Infectious disease experts stress that preventing COVID-19 through wide use of vaccines remains the best way to control the pandemic, but only 58 percent of Americans are fully vaccinated and access in many parts of the world is limited.

Also Read: What happens when the COVID-19 vaccines enter the body? A road map for kids and grown-ups

Pfizer’s drug, part of a class known as protease inhibitors, is designed to block an enzyme the coronavirus needs in order to multiply.

Merck’s molnupiravir has a different mechanism of action designed to introduce errors into the genetic code of the virus. Merck has already sold millions of courses of the treatment, which was approved this week by U.K. regulators, to the United States, the U.K. and others.

Britain said earlier this month it had secured 250,000 courses of Pfizer’s antiviral.

Pfizer is also studying whether its pill could be used by people without risk factors for serious COVID-19 as well as to prevent coronavirus infection in people exposed to the virus.

(Text inputs from Reuters)

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Pfizer/BioNTech COVID-19 vaccine effectiveness drops after 6 months, says study

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The effectiveness of the Pfizer Inc/BioNTech SE vaccine in preventing infection by the coronavirus dropped to 47% from 88% six months after the second dose, according to data published on Monday that U.S. health agencies considered when deciding on the need for booster shots.

The data, which was published in the Lancet published medical journal, had been previously released in August ahead of peer review.

The analysis showed that the vaccine’s effectiveness in preventing hospitalization and death remained high at 90% for at least six months, even against the highly contagious Delta variant of the coronavirus.

The data suggests that the drop is due to waning efficacy, rather than more contagious variants, researchers said.

Researchers from Pfizer and Kaiser Permanente studied electronic health records of roughly 3.4 million people who were members of Kaiser Permanente Southern California between December 2020 – when the vaccine first became available – and August of 2021.

“Our variant-specific analysis clearly shows that the (Pfizer/BioNTech) vaccine is effective against all current variants of concern, including Delta,” said Luis Jodar, senior vice president and chief medical officer at Pfizer vaccines.

A potential limitation of the study was a lack of data on adherence to masking guidelines and occupations in the study population, which could have affected frequency of testing and likelihood of exposure to the virus.

Vaccine effectiveness against the Delta variant was 93% after the first month, declining to 53% after four months. Against other coronavirus variants, efficacy declined to 67% from 97%.

“To us, that suggests Delta is not an escape variant that is completely evading vaccine protection,” said study leader Sara Tartof with Kaiser Permanente Southern California’s Department of Research & Evaluation.

“If it was, we would probably not have seen high protection after vaccination, because vaccination would not be working in that case. It would start low, and stay low.”

Testing for variants is more likely to fail in vaccinated individuals, which could lead to overestimation of variant-specific effectiveness in the study, the authors cautioned.

The U.S. Food and Drug Administration has authorized the use of a booster dose of the Pfizer/BioNTech vaccine for older adults and some Americans at high-risk of getting infected. Scientists have called for more data on whether boosters should be recommended for all.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Pfizer begins study of COVID oral drug

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Pfizer said on Monday it has started a large study testing its investigational oral antiviral drug for the prevention of COVID-19 infection among those who have been exposed to the virus.

The drugmaker and its rivals, including U.S.-based Merck & Co Inc (MRK.N) and Swiss pharmaceutical Roche Holding AG (ROG.S), have been racing to develop an easy-to-administer antiviral pill for COVID-19.

The mid-to-late-stage study will test Pfizer’s drug, PF-07321332, in up to 2,660 healthy adult participants aged 18 and older who live in the same household as an individual with a confirmed symptomatic COVID-19 infection.

In the trial, PF-07321332, designed to block the activity of a key enzyme needed for the coronavirus to multiply, will be administered along with a low dose of ritonavir, an older medication widely used in combination treatments for HIV infection.

To date, Gilead Sciences Inc’s (GILD.O) intravenous drug remdesivir is the only approved antiviral treatment for COVID-19 in the United States.
Pfizer has also started another study of PF-07321332 in non-hospitalized, symptomatic adult patients.

Merck and partner Ridgeback Biotherapeutics recently launched a late-stage trial of their experimental drug molnupiravir for prevention of the COVID-19 infection. read more
Molnupiravir is also being studied in a late-stage trial in non-hospitalized patients to see if it reduces the risk of hospitalization or death.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Pfizer CEO hopes life will return to normal in a year; but with booster shots

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Nearly two years after the onset of the COVID-19 pandemic, ramped up vaccination drives point to some light at the end of the tunnel. The head of one of the vaccine makers believes life will return to relative normalcy by next year.

Albert Bourla, the CEO and Chairman of Pfizer, said life will slowly return to how it used to be though annual booster shots may be needed to remain protected against any new variants.

“Within a year I think we will be able to come back to normal life,” Bourla said in an interview on ABC.

His statements echo those by the CEO of fellow vaccine manufacturer Moderna.  “As of today, in a year, I assume,” Moderna CEO Stéphane Bancel told the Swiss newspaper Neue Zuercher Zeitung on September 23.

Also read: COVID 3rd wave unlikely with no new variants, need more data to decide on vaccination of kids: Dr Gangandeep Kang

The return to normal will largely rely on robust vaccination drives along with focus on annual booster shots against both existing and yet to-emerge COVID-19 variants.

The US Centres for Disease Control and Prevention (CDC), and the Food and Drugs Administration (FDA) have recently given the go-ahead for booster shots for at-risk populations, and those who are immunocompromised.

Dr Rochelle Walensky, head of the CDC, went against the recommendation of the expert panel and allowed booster shots to be distributed to those in high-risk occupational and institutional settings. Her decision came at a time when faltering vaccination rates in the US have caused a massive resurgence in cases driven by the Delta variant.

“The most likely scenario for me is that, because the virus is spread all over the world, that it will continue seeing new variants that are coming out,” Bourla said.

“Also we will have vaccines that they will last at least a year, and I think the most likely scenario is annual vaccination, but we don’t know really, we need to wait and see the data,” he added.

While booster shots remain on the agenda for several nations like the US, Germany and France, among others, several poorer nations have been struggling to give even the first dose to their citizens. Amid the growing vaccination gap, the World Health Organization (WHO) has asked countries to defer booster programmes until the end of the year so that more doses may be passed on to poorer nations.

Moderna and Pfizer are two of the companies that have faced increasing criticism from health activists for not sharing their technology to ramp up production of their vaccines. While Pfizer has been against waiving intellectual property rights on its vaccine for the duration of the pandemic, Moderna has famously said it would not be enforcing the patent laws on its vaccine while the pandemic remains a threat.

However, without proper technology sharing, Moderna’s offer has not been taken up by other pharmaceutical companies.

Also read: COVID-19 vaccination picks pace in India; these states have outdone several nations

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Israel to offer 3rd COVID booster shot to older citizens

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Israels prime minister on Thursday announced that the country would offer a coronavirus booster to people over 60 who have already been vaccinated.

The announcement by Naftali Bennett makes Israel the first country to offer a third dose of the Pfizer/BioNtech vaccine to its citizens on a wide scale.

The decision came at a time of rising infections and concerns that the vaccines efficacy dwindles over time.

THIS IS A BREAKING NEWS UPDATE. APs earlier story follows below.

JERUSALEM: A leading Israeli health provider on Thursday said it would soon begin offering a third, booster COVID-19 shot to patients over the age of 60 who have already been vaccinated against the coronavirus.

This would make Israel the first country with Western vaccines to offer its vaccinated citizens a third dose. Previously, boosters were used in some countries with the Chinese and Russian vaccines.

Maccabi, one of Israel’s four publicly funded health maintenance organizations, said its members could already register and the vaccinations would start on Sunday.

The announcement came shortly ahead of a nationally televised news conference by Prime Minister Naftali Bennett, who is expected to unveil a nationwide booster shot program.

Neither the United State nor the European Union have officially recommended coronavirus booster shots. Its not yet proven if a third dose helps and, if so, who needs one and when. The first large study of the strategy is beginning in thousands of patients in Norway.

Early this year, Israel carried out one of the world’s most aggressive and successful vaccination campaigns. Over 57% of the countrys 9.3 million citizens have received two doses of the Pfizer/BioNTech vaccine, and over 80% of the population over 40 is vaccinated.

The vaccination program allowed Israel to reopen its economy ahead of other countries. But there are signs that the vaccine’s efficacy wears off over time, and Israel has seen a spike in cases of the new delta variant, even among people who are vaccinated.

People over the age of 60 who were vaccinated more than five months ago will be eligible for the booster, Maccabi said.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

COVID-19: Pfizer and BioNTech developing updated vaccine to combat Delta variant

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Pfizer and its partner BioNTech have announced on July 8 that they will be  developing a booster shot of their COVID-19 vaccine. The statement from the companies also said a modification to the vaccine was also being tested to particularly combat the Delta variant.

The Delta variant of SARS CoV-2, which was first identified in India and caused the devastating second wave in the country, has been responsible for rising cases around the world. The variant is believed to be behind the recent surge in COVID-19 cases in Australia, Portugal, Malaysia and the UK, among others.

“While Pfizer and BioNTech believe a third dose of BNT162b2 has the potential to preserve the highest levels of protective efficacy against all currently known variants including Delta, the companies are remaining vigilant and are developing an updated version of the Pfizer-BioNTech COVID-19 vaccine that targets the full spike protein of the Delta variant,” read the companies’ joint statement.

The effectiveness of first-generation COVID-19 vaccines has been called to question against the Delta and the Delta Plus variants due to the unique mutations in their spike proteins.

Delta is known to be over 60 percent more transmissible than the Alpha variant, which was first found in the UK. Along with increased transmissibility, the variant was also more effective at evading the body’s immune response.

While more research is needed, the Delta Plus variant is expected to be even more transmissible and more efficient at completely evading the immune response in the human body. Others like Lambda, while not categorised as ‘variants of concern,’ are also being monitored closely.

The third dose of the ‘Comirnaty’ vaccine, as it is officially branded, will seek to improve the effectiveness of the mRNA-based vaccine against emerging variants. The initial testing of the third dose, given after six months of the second one, has shown encouraging results said the company. The company will be conducting more trials before sending the data to the US Food and Drugs Administration (FDA) for approval.

The trials for the upgraded vaccine formula for the Delta variant are slated to start in August, subject to regulatory approvals.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Pfizer mRNA COVID-19 vaccine may cost Rs 730 a dose in India: Report

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The Pfizer mRNA vaccine against COVID-19 may be available in India for as little as Rs 730, according to reports. The sub-$10 price would be the cheapest price for the vaccine anywhere around the world.

“It is a single-digit price per dose. This is a not-for-profit price for the government’s immunisation programme,” Business Standard reported citing sources.

At a price below or at $10, the vaccine would be available in India at nearly half the cost of what it is being sold for in other countries. Currently, the vaccine is priced at $19.5 in the US and at $21 in the UK. Price negotiations are still ongoing in the EU where the vaccine was earlier available for $18.9 a dose but may soon cost $23.2.

“Pfizer has offered to make the required doses of our COVID-19 vaccine available at a not-for-profit price for India, as for all low and lower-middle-income countries, once we have the necessary regulatory clearance,” a Pfizer spokesperson said.

India may soon be able to receive 50 million (5 crore) doses of the vaccine, according to reports. Pfizer is in talks with the Centre but the pharma company’s demand to be granted indemnity continues to be a roadblock.

“Currently, as our discussions with the government of India are ongoing and confidential, we cannot provide further details,” the spokesperson added.

The three other COVID-19 vaccines currently available in the market are Russia’s Sputnik V, Covishield from Oxford-AstraZeneca and produced by the Serum Institute of India, and Covaxin from Bharat Biotech.

Sputnik V is currently priced at Rs 995 for the private market, while Covaxin costs Rs 12,00 and Covishield Rs. 600.

The prices for the vaccines for the central government were capped at Rs. 150, but sources suggest that those prices will be renegotiated.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow