Pfizer Lifts 2021 Forecasts, Sees $36bn In COVID-19 Vaccine Sales

This file photo was taken on May 8, 2021, shows vials of Pfizer-BioNTech vaccine at a Covid-19 vaccination center in Paris, amid the campaign of vaccination against the coronavirus.

 

 

Pfizer again lifted its 2021 profit and revenue outlook on Tuesday, bolstered by the latest surge in Covid-19 vaccinations, including regulatory approvals for boosters and shots for younger populations.

The drugmaker now expects 2.3 billion dosage deliveries of the Covid-19 vaccine in 2021 for the shots jointly produced with Germany’s BioNTech, up 200 million from its previous forecast in July. That will bring total 2021 revenues for the vaccine to $36 billion, from $33.5 billion.

Pfizer said higher forecast 2021 results reflects the boost from the Covid-19 vaccine, as well as the performance of Pfizer’s broader business.

On Friday, US health authorities approved Pfizer’s vaccine for children aged five to 11, paving the way for 28 million young Americans to soon get immunized.

Shares rallied on the announcement, which comes on the heels of similar earnings releases by Pfizer in May and July that also showed how the vaccine has transformed the company’s financial performance over the last year.

In the most recent quarter, the company’s revenues were $24.1 billion, more than double the level in the year-ago period, with $13 billion coming from revenues tied to the Covid-19 vaccine.

Profits shot up to $8.1 billion, compared with $1.5 billion in the year-ago period.

While Pfizer’s financial performance has thrived thanks to the Covid-19 vaccine, the company has been criticized by non-governmental organizations for placing profits above public health in its dealings with governments over the shot.

A recent report by advocacy group Public Citizen accused the company of “bullying” authorities and called for the US government to assume greater leverage with the company.

Pfizer has defended its comportment, saying in Tuesday’s press release that it plans to sell the US government one billion doses “at a not-for-profit price to be donated to the world’s poorest nations at no charge to those countries.”

Pfizer shares jumped 2.9 percent to $44.92 in pre-market trading.

Pfizer Lifts Outlook As COVID-19 Vaccine Drives Results

The Pfizer Covid-19 vaccine is prepared for administration at a vaccination clinic. Frederic J. BROWN / AFP

 

Pfizer again boosted its 2021 profit and revenue outlook on Tuesday, bolstered by the latest surge in Covid-19 vaccinations, including regulatory approvals for boosters and shots for younger children.

The company now expects to deliver 2.3 billion doses in 2021 of the Covid-19 vaccine jointly produced with Germany’s BioNTech, 200 million more than its previous forecast in July, as it announced an increase in its research and development budget tied to the vaccination push.

US health authorities on Friday approved Pfizer’s vaccine for children aged five to 11, paving the way for 28 million young Americans to soon get the shot against the disease.

The company’s shares rallied on the announcement, which comes on the heels of similar upbeat earnings in May and July also showing how the vaccine has transformed the drugmaker’s financial performance over the last year.

“Despite all we have been able to accomplish to date, we remain focused on our future, not our past,” said Chief Executive Albert Bourla. “Our ultimate goal is to help bring this pandemic to an end as quickly as possible, but also to apply the lessons we have learned through our work on the vaccine to all of our therapeutic areas.”

Bourla said the company had about three-fourths of the US market share in late October and about 80 percent in the European Union, the result “of our booster being the first to receive emergency use authorization and our two-dose series being preferred by some countries around the world for use in certain younger populations.”

– More research planned –

In the most recent quarter, the company brought in $24.1 billion in revenue, more than double the level in the year-ago period, with $13 billion coming tied to the Covid-19 vaccine.

Pfizer now projects total 2021 revenues for the vaccine of $36 billion, up from $33.5 billion in 2020.

Profits shot up to $8.1 billion, compared with $1.5 billion in the year-ago period.

Pfizer increased 2021 its research and development budget by $400 million due to more projects on Covid-19 vaccines and related mRNA-based projects, now estimating spending in a range of between $10.4 billion and $10.9 billion.

The press release describes clinical research on an Influenza mRNA vaccine under development, “the first in a planned wave of Pfizer investigational programs leveraging mRNA technology for Pfizer.”

Bourla has spoken of the potential for Covid-19 vaccines to produce “durable demand,” similar to that of the flu vaccine.

While Pfizer’s financial performance has thrived thanks to the Covid-19 vaccine, the company has been criticized by non-governmental organizations for placing profits above public health in its dealings with governments over the shot.

A recent report by advocacy group Public Citizen accused the company of “bullying” authorities and called for the US government to assume greater leverage with the company.

Pfizer has defended its actions, saying in Tuesday’s press release that it plans to sell the US government one billion doses “at a not-for-profit price to be donated to the world’s poorest nations at no charge to those countries.”

Excluding the Covid-19 vaccine, Pfizer lowered its 2021 revenue forecast slightly and raised its profit outlook modestly.

The company saw higher sales of anti-blood clot drug Eliquis and of the heart drug Vyndaqel.

Sales were dented somewhat by a recall of Chantix, an anti-smoking drug. Pfizer enacted a voluntary recall of the drug due to a “theoretical potential increased cancer risk in humans,” the Food and Drug Administration said in September.

Pfizer shares jumped 3.0 percent to $44.96 in pre-market trading.

Pfizer Says COVID-19 Booster Shot 95.6% Effective

An illustration picture shows vials with Covid-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020. JUSTIN TALLIS / AFP
An illustration picture shows vials with Covid-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020. JUSTIN TALLIS / AFP

 

 

A booster shot of the anti-COVID-19 vaccine developed by Pfizer/BioNTech is 95.6 per cent effective against symptomatic infection, according to trial data published by the makers on Thursday.

The clinical phase three trial with “10,000 participants 16 years of age and older” showed “a relative vaccine efficacy of 95.6 per cent against disease during a period when Delta was the prevalent strain”, the companies said in a statement.

The study presented the “first results” of a booster trial, with a third shot of the vaccine demonstrating a “favourable safety profile”.

“These results provide further evidence of the benefits of boosters as we aim to keep people well-protected against this disease,” said Pfizer CEO Albert Bourla.

The preliminary results would be shared with regulatory agencies “as soon as possible”, the companies said in the statement.

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Several countries have already approved COVID-19 booster shots to increase immunity in people who have already been vaccinated, but whose protection may have dipped after several months, per some studies.

In the United States, the federal Food and Drug Administration (FDA) approved a third dose in September for everyone aged 65 and up, as well as people at high risk of developing severe COVID.

The European Medicines Agency (EMA) approved a booster for over-18s at the beginning of October, allowing national regulators to decide which groups should be eligible first.

In Israel, authorities have gone further, approving booster shots for everyone aged 12 and over.

AFP

US Donates 3.5 Million Pfizer COVID-19 Vaccines To Nigeria

Used vials of Pfizer-BioNTech’s Comirnaty COVID-19 vaccine against the novel coronavirus stand next to a syringe in a doctor’s practice in Suhl, Germany, on May 6, 2021.
Christof STACHE / AFP

 

A total of 3,577,860 doses of the Pfizer vaccine have arrived in Nigeria from the United States.

This is according to a statement released by the United States Mission in Nigeria on Thursday.

“The U.S. Mission in Nigeria is pleased to announce the arrival of 3,577,860 doses of Pfizer vaccine for the public health and benefit of the Nigerian people through COVAX, the worldwide initiative ensuring equitable access to COVID-19 vaccines,” the statement said.

READ ALSO: Vaccinated Persons May Be Required To Take A Third Shot – Lagos Govt

“The U.S. shipment arrived at the Nnamdi Azikiwe International Airport in Abuja on October 14. The shipment will bring the total number of U.S.-bilaterally donated doses to Nigeria to over 7.5 million. The U.S. also contributed to the first multilateral donation of AstraZeneca vaccine in March 2021.

“Overall, COVAX has provided Nigeria with over 10 million doses to date.”

The mission noted that safe and effective vaccines remain the best tool to ending the pandemic.

“The United States has pledged to purchase and donate 1.1 billion COVID-19 vaccine doses worldwide, and to date has delivered more than 180 million doses to more than 100 countries,” the statement added.

Pfizer Asks For Authorisation To Vaccinate Children Aged 5-11

File Photo of the Pfizer-BioNTech vaccine at a COVID-19 vaccination center

 

US drugmaker Pfizer said Thursday it has formally requested emergency use authorization for its COVID-19 vaccine in children aged five to 11.

Children have been infected in greater numbers in the latest coronavirus wave driven by the Delta variant, and inoculating young people is seen as key to keeping schools open and helping end the pandemic.

In late September, Pfizer and BioNTech, which co-developed the vaccine, began submitting data to the Food and Drug Administration regulators for the highly anticipated authorization.

Pfizer tweeted early Thursday that the two companies had “officially submitted our request” to the FDA “for Emergency Use Authorization (EUA) of our #COVID19 vaccine in children 5 to <12.”

“We’re committed to working with the FDA with the ultimate goal of helping protect children against this serious public health threat,” Pfizer said.

Following the announcement White House Covid coordinator Jeff Zients told CNN that “I think we can all agree that getting a safe and effective vaccine for kids five to 11 is a really important next step in our fight against the virus.”

Children in the 5-11 age group received a two-dose regimen of 10 micrograms in the trial, compared with 30 micrograms for older age groups. The shots were given 21 days apart.

The FDA has previously said that once the formal submission was completed, the agency would complete its review “likely in a matter of weeks rather than months.”

The Pfizer-BioNTech vaccine has been granted full FDA approval for those age 16 and up.

Over 3.5 Million Pfizer Vaccines Expected From US Govt – FG

The Pfizer Covid-19 vaccine is prepared for administration at a vaccination clinic. Frederic J. BROWN / AFP

 

The Federal Government on Monday said over 3.5 million doses of Pfizer vaccine are expected from the United States, as part of measures to ensure all Nigerians get vaccinated against the virus.

Briefing reporters in Abuja, Chairman of the Presidential Steering Committee (PSC) on COVID-19, Boss Mustapha, said notable progress is being made in the area of vaccines.

“Over 3.5 million doses of Pfizer are being expected from the US Government this month while about four million doses of AstraZeneca are being expected early next month,” he said.

“Nigeria will be receiving over one million doses of Johnson and Johnson (J&J) shipments on a monthly basis. The PSC is committed to accessing enough vaccines for the 70% eligible persons in the country in record time.”

Mustapha said the PSC has taken note of the challenges raised by travellers who visit the National International Travel Portal in compliance with travel protocols.

He lamented that some airport staff were not diligent in the discharge of their duties with respect to the quarantine procedure.

According to him, the PSC “has similarly noted with dismay, fraudulent activities perpetrated at our international airports by on-duty staff, who extort money out of those who equally wish to evade quarantine requirement.”

Mustapha, who is also the Secretary to the Government of the Federation, explained that the authorities are conducting the necessary investigations into various reports received.

He added, “On the United Kingdom advisory on COVID-19 vaccines and changes to international travel rules, the British High Commissioner to Nigeria has stated that the UK government, of course, supports the vaccination programme in the country with vaccines irrespective of where they were manufactured.

“They will, however, open up international travels using a standardised COVID-19 vaccination certification process, to allow for ease of travels from countries – Nigeria inclusive.”

US Authorizes Pfizer COVID-19 Booster For The Elderly And High-Risk

File photo: A nurse prepares a dose of the Pfizer-Biontech Covid-19 corona virus vaccine. (Photo by Bodo Schackow / POOL / AFP)

 

The United States on Wednesday authorized the use of boosters of Pfizer’s Covid-19 vaccine for people aged over 65, as well as adults at high risk of severe disease and those in high-exposure jobs.

The announcement means a significant part of the population — amounting to tens of millions of Americans — are now eligible for a third shot six months after their second.

“Today’s action demonstrates that science and the currently available data continue to guide the FDA’s decision-making for COVID-19 vaccines during this pandemic,” said Janet Woodcock, acting head of the Food and Drug Administration, in a statement.

The decision was expected and came after an independent expert panel convened by the regulatory agency last week voted in favor of recommending the move.

The panel, however, rejected an initial plan by the White House to fully approve Pfizer boosters to everyone aged 16 and over, in what amounted to a rare rebuke of President Joe Biden’s administration.

The group of vaccinologists, infectious disease specialists and epidemiologists concluded that the benefit-risk balance differed for younger people, especially young males who are more susceptible to myocarditis.

– More boosters debated –

Pfizer Covid-19 boosters are currently being debated by a separate body of experts convened by the Centers for Disease Control and Prevention (CDC), which may recommend further specifics about recipients.

For example, if obesity is considered as putting a person “at high risk of severe Covid,” that definition would cover more than 42 percent of the US population aged over 20.

The CDC may also have to define which workplaces and other settings might lead to “frequent institutional or occupational exposure to SARS-CoV-2.”

For its part, the FDA indicated this would cover “health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others.”

READ ALSO: Nigeria Reports Two More COVID-19 Deaths, 377 New Infections

The FDA’s emergency use authorization (EUA) applies to those aged 18 and up for the high risk of severe disease and high-exposure categories. It also only applies to Pfizer’s vaccine.

Recipients of Moderna and Johnson & Johnson, the other US-authorized vaccines, will now await news for when they, too, might become eligible for another shot.

A number of studies have shown two doses of Pfizer or Moderna, or a single shot of J&J, continue to confer high protection against severe outcomes — but this is slightly reduced for the elderly.

The World Health Organization has called for a moratorium on wealthy countries giving out boosters, while many countries — especially those in Africa — have barely begun their immunization campaigns.

The United States argues, however, it is possible to both help middle- and lower-income nations while also protecting its own vulnerable people.

On Wednesday, President Biden announced the United States would buy 500 million more Pfizer doses for the world, bringing its total contribution of the global supply to 1.1 billion.

Speaking to CNN on Sunday, top government scientist Anthony Fauci said that more research is needed to make a decision on whether a booster shot is warranted for the general public.

“As we said in the beginning, we would want to plan for the possibility of vaccinating all those who have gotten their initial vaccination with Pfizer,” Fauci said. “And it was always pending the evaluation of all of the totality of the data from the United States, from Israel, and any bit of data that we could get by the advisory committee to the FDA.”

Fauci added that the FDA panel decided against a third shoot for everybody aged 16 and over “in the proper deliberative process and they came up with a recommendation.”

AFP

US To Donate Extra 500 Million COVID-19 Vaccines, Says Biden

US President Joe Biden convenes a virtual Covid-19 Summit on the sidelines of the UN General Assembly, on September 22, 2021, in the South Court Auditorium of the White House in Washington, DC. – Biden urged leaders at summit to make sure 70 percent of their populations are covered by next September. (Photo by Brendan Smialowski / AFP)

 

President Joe Biden opened a Covid-19 summit of world leaders Wednesday with a promise to donate a “historic” extra 500 million vaccines to countries struggling to push back against the pandemic.

“This is an all-hands-on-deck crisis,” Biden said. “America will become the arsenal for vaccines as we were the arsenal for democracy in World War II.”

The pledge from Biden at the summit, held virtually from the White House, brings the total US commitment of donated vaccines to 1.1 billion — more than the rest of the world combined.

“The US has already shipped 160 million of these doses to 100 countries,” the White House said in a statement. “For every one shot we’ve put in an American arm to date, we are now donating three shots globally.”

The new tranche of half a billion vaccines will be from Pfizer and aimed at poorer countries.

Biden was also due to challenge world leaders to vaccinate 70 percent of every country by September 2022, the White House said.

In his opening remarks, he stressed that the surge of vaccines must only be donated, with no “political” strings attached — a veiled dig at China in particular.

The United States and other wealthy countries have been criticized by the World Health Organization for their plans to roll out booster shots for elderly and high-risk populations, while much of the world faces a severe shortage in doses.

But a senior US administration official told reporters that Washington is “proving that you can take care of your own, while helping others as well.”

On Tuesday, in his first speech to the UN as president, Biden told delegates that the United States had put more than $15 billion towards the global Covid response and shipped more than 160 million doses to other countries.

– 70 percent target –

Despite the development of safe and highly effective vaccines in record-breaking time, huge disparities exist between countries with ample supply and others that have barely begun their immunization campaign.

Just 3.6 percent of Africa’s eligible population has been inoculated — compared with an average of more than 60 percent in Western Europe.

The summit — technically held on the sidelines of the UN General Assembly — saw Biden and US Ambassador to the UN Linda Thomas-Greenfield hosting a wide variety of health and foreign leaders.

They included UN Secretary-General Antonio Guterres, World Health Organization chief Tedros Adhanom Ghebreyesus, and the heads of Britain, Canada, the European Union, Indonesia, and South Africa.

Washington will seek to rally the world around three goals, the administration official said.

These are: increasing vaccine supply; saving lives now by resolving the oxygen crisis and access to testing, medicine and therapeutics; and lastly improving future preparedness.

On vaccines, Biden will set an “ambitious target, which will require all countries to step up, so that every country, including low income and low middle income countries can achieve 70 percent vaccination before” next year’s UN General Assembly, the official said.

While the latest global coronavirus wave peaked in late August, the virus continues to spread rapidly, particularly in the United States, which is officially the worst-hit country.

Some 4.7 million have died since the outbreak began in China in December 2019, according to an AFP tally from official sources.

AFP

COVID Jab Safe For Children Aged 5-11, Says Pfizer

This file photo taken on May 8, 2021, shows vials of the Pfizer-BioNTech vaccine at a Covid-19 vaccination center in Paris, amid the campaign of vaccination against the coronavirus.

 

Pfizer and BioNTech on Monday said trial results showed their coronavirus vaccine was safe and produced a robust immune response in children aged five to 11, adding that they would seek regulatory approval shortly.

The vaccine would be administered at a lower dosage than for people over 12, they said.

“In participants five to 11 years of age, the vaccine was safe, well tolerated and showed robust neutralising antibody responses,” US giant Pfizer and its German partner said in a joint statement.

They plan to submit their data to regulatory bodies in the European Union, the United States and around the world “as soon as possible”.

The trial results are the first of their kind for children under 12, with a Moderna trial for six-11 year olds still ongoing.

Both the Pfizer and Moderna jabs are already being administered to adolescents over 12 and adults in countries around the globe.

Although children are considered less at risk of severe Covid, there are concerns that the highly contagious Delta variant could lead to more serious cases.

Innoculating children is also seen as key to keeping schools open and helping end the pandemic.

“We are eager to extend the protection afforded by the vaccine to this younger population,” said Pfizer CEO Albert Bourla, noting that “since July, paediatric cases of COVID-19 have risen by about 240 percent in the US”.

Kids in the 5-11 age trial group received a two-dose regimen of 10 microgrammes in the trial, compared with 30 microgrammes for older age groups, the companies said. The shots were given 21 days apart.

The 10 microgramme dose was “carefully selected as the preferred dose for safety, tolerability and immunogenicity” for that age group, the statement said.

– Under-5s before year-end –
The side effects were “generally comparable to those observed in participants 16 to 25 years of age”, it added.

Among the most commonly reported side effects in the past have been pain and swelling at the injection site as well as headache, chills and fever.

Israel has already given special authorisation to vaccinate children aged 5-11 who are “at significant risk of serious illness or death” from Covid, using the Pfizer jab at the lower dosage.

Pfizer and BioNTech are also trialling their vaccine on infants aged six months to two years, and on children aged two to five.

The topline results for those trials are expected “as soon as” the fourth quarter of this year, the companies said.

All together, up to 4,500 children aged six months to 11 years have enrolled in the Pfizer-BioNTech trials in the US, Finland, Poland and Spain.

Like its Moderna rival, the Pfizer jab is based on novel mRNA technology that delivers genetic instructions to cells to build the coronavirus spike protein, in order to evoke antibodies when bodies encounter the real virus.

US Grants Full Approval To Pfizer COVID-19 Vaccine

A health worker shows a vial of the Pfizer-BioNTech vaccine against COVID-19 at the Pascual Guerrero Olympic stadium, in Cali, Colombia, on April 26, 2021. Luis ROBAYO / AFP

 

The US Food and Drug Administration on Monday fully approved Pfizer’s Covid-19 vaccine, a move expected to trigger a new wave of vaccine mandates as the Delta variant batters the country.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the Covid-19 pandemic,” acting FDA Commissioner Janet Woodcock said in a statement.

“While millions of people have already safely received Covid-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated.”

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The Covid vaccine, which may now be marketed under its brand name Comirnaty, is the first to receive full approval.

Tens of millions of shots have already been administered under an emergency use authorization (EUA) that was granted on December 11, 2020.

The decision to award it approval was based on updated data from the drug’s clinical trial, including a longer duration of follow-up, with safety and effectiveness evaluated among more than 40,000 people.

The US military has previously announced it will mandate the vaccine as soon as it receives full approval, and a slew of private businesses and universities are expected to follow.

The vaccine remains available under emergency use authorization to children aged 12 to 15, but because it has now been fully approved, physicians may prescribe it to children under 12 if they believe it will be beneficial.

AFP

Israel To Begin Covid Booster Shots For Over 40s

An Israeli health worker administers a third dose of the Pfizer-BioNtech Covid-19 vaccine to Jewish ultra-Orthodox man at a religious neighbourhood in Jerusalem on August 19, 2021. AHMAD GHARABLI / AFP
An Israeli health worker administers a third dose of the Pfizer-BioNtech Covid-19 vaccine to Jewish ultra-Orthodox man at a religious neighbourhood in Jerusalem on August 19, 2021. AHMAD GHARABLI / AFP

 

Israelis aged 40 and over will be able to receive coronavirus vaccine booster shots starting this weekend, Health Minister Nitzan Horowitz said Thursday, as the country battles a spike in infections.

Israel was one of the first countries to launch a vaccination drive in mid-December via an agreement with Pfizer to obtain millions of paid vaccine doses in exchange for sharing data on their effectiveness.

The inoculation campaign was hailed as a success story that helped drastically reduce infections in the country of nine million.

But cases have been rising due to the spread of the Delta variant among the unvaccinated and waning immunity in others.

To try and contain the spread, authorities last week began administrating a booster shot to those aged 50 and older, after starting a campaign for over-60s late last month.

Horowitz, who is among those who have received a third dose, tweeted Thursday that people aged 40 and over will be able to get a booster shot from Sunday.

“We have vaccines for everyone and now those 40 and older can receive a third dose,” he wrote. “The vaccine is effective. Let’s stop this Delta.”

Israel has recorded more than 970,000 coronavirus infections since the pandemic started early last year, and over 6,700 deaths.

More than 5.4 million people have received two doses of the vaccine, while 1.2 million have had a third jab.

Earlier this month, the World Health Organization called for a moratorium on Covid-19 vaccine booster shots to help ease the drastic inequity in dose distribution between rich and poor nations.

AFP

No Need To Adapt Pfizer Vaccine For COVID-19 Variants, Says BioNTech Chief

File: JOEL SAGET / AFP

 

The first generation vaccine developed by BioNTech-Pfizer works against coronavirus variants such as the Delta strain and does not need to be modified for the moment, the chief executive of German company BioNTech said Monday.

“It is quite possible that in the next six to 12 months, further variants will emerge and that would require adaptation of the vaccine but it is at the moment not yet the case,” Ugur Sahin told journalists.

A decision to make a switch should be made only if it is clear that the vaccine failed to work or is only offering sub-par protection against the virus.

The fast-changing situation meant that getting the timing for the change right was also crucial.

“Making a decision at the moment might turn out to be wrong in three or six months if another variant is dominating. Therefore the timing of the decision must be appropriate,” he said.

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“At the moment we have a good understanding that the booster vaccine with the parental strain is completely sufficient,” stressed Sahin.

BioNTech’s partner Pfizer has also repeatedly amplified the case for booster shots amid the latest wave of infections.

Countries including France and Germany have said they will begin offering the additional shot to the elderly and the most vulnerable from September.

BioNTech-Pfizer have shipped around one billion doses of their vaccines to more than 100 countries or territories around the world.

They are expecting their annual manufacturing capacity to reach three billion doses by year’s end, before climbing to four billion doses in 2022.

AFP