Pfizer Raises 2021 Outlook On Surging COVID-19 Vaccine Sales

In this file photo The Pfizer logo is viewed on their world headquarters in Manhattan on May 5, 2014 in New York City. 

 

 

Pfizer lifted its annual revenue and profit projections Wednesday on surging demand for Covid-19 vaccine doses as executives amplified their case for booster shots amid the latest wave of infections.

The two-shot inoculation accounted for more than 40 percent of Pfizer’s sales in the second quarter, boosting revenues sharply compared with the same three months of 2020.

Pfizer Chief Executive Albert Bourla said more than a billion doses of the vaccine have been delivered so far.

The US drugmaker, which has partnered with Germany’s BioNTech on the vaccine, now expects to deliver 2.1 billion doses this year, generating $33.5 billion in sales, topping the May forecast for $26 billion in sales on 1.6 billion doses.

Bourla said “the speed and efficiency of our efforts with BioNTech to help vaccinate the world against Covid-19 have been unprecedented.”

In the second quarter, the company logged profits of $5.6 billion, up 59 percent from the prior year on a 92 percent increase in revenues to $19 billion.

Recent commercial developments for the Pfizer-BioNTech vaccine venture include a May agreement with the European Union, a June deal with the United States for 500 million doses to donate to the poorest countries, and a letter of intent signed in July with the Biovac Institute to manufacture the vaccine in Africa.

The pre-tax profit margin on the Covid-19 vaccine was in the high-20 percent range, the same as the earlier forecast, the company said.

That has raised the ire of non-governmental organizations such as Public Citizen, which has accused Pfizer of “profiteering” on the pandemic and called on world leaders to launch a multi-billion dollar campaign to build vaccine manufacturing capacity and “vaccinate the world.”

But Pfizer, which has resisted efforts to roll back patent protections on vaccines, has defended its policies, saying it has priced the shots moderately in middle income countries and at cost for low-income countries.

Bourla also said he expects Pfizer to deliver one billion doses to middle-and-low income countries this year and another one billion in 2022.

The company expects to produce a total of three billion Covid-19 vaccines, meaning additional contracts could be announced this year.

– A third shot? –
Much of the 90-minute conference call with Wall Street analysts focused on the prospect for additional vaccine-related revenue, notably from booster shots that Pfizer has argued will be needed to contain Covid-19.

Bourla has said he expects “durable demand” for Covid-19 vaccines, similar to that of the annual flu shot.

Pfizer has launched clinical studies on a possible third dose of the vaccine, and plans to submit data on the booster shot to the government next month.

The company’s presentation included charts showing a third jab boosting effectiveness against new variants, including fast-spreading Delta.

“What we have said for months is that we believe…. we will need a booster eight to 12 months from the second dose, and we have seen with the Delta that might be needed a little bit earlier for some parts of the population,” Bourla told analysts on a conference call.

US health officials have thus far been circumspect on the need for a third shot for the broad population, but officials are studying the need in immunocompromised people.

“Americans who have been fully vaccinated do not need a booster shot at this time,” according to a July 8 statement from the Food and Drug Administration and the Centers for Disease Control and Prevention.

“We are prepared for booster doses if and when the science demonstrates that they are needed,” the agencies said.

On Tuesday, the Centers for Disease Control and Prevention shifted course and directed vaccinated people to resume wearing masks indoors in high-risk parts of the United States.

Bourla suggested government’s response thus far on boosters reflects the normal process.

“We haven’t submitted the data yet, so I don’t think the FDA or CDC can speak because they have very different authority when they speak,” Bourla said.

Shares of Pfizer rose 2.9 percent to $43.31 in midday trading.

South Africa Begins Second Phase Of COVID-19 Vaccination

PHOTO USED TO ILLUSTRATE THE STORY: Residents of Snake Park in Soweto, a town in the city of Johannesburg, South Africa PHOTO: MARCO LONGARI / AFP

 

South Africa on Monday launched its second phase of COVID-19 vaccinations targeting people who are aged 60 years and above.

Health Minister Zweli Mkhize said late Sunday that the target would be achieved if the anticipated orders of vaccines were delivered on time.

“We will begin to vaccinate citizens 60 years and older, who are the most vulnerable for becoming ill or dying of Covid-19,” the minister said during a webinar.

The immunisation of health workers started in February when it became the first country worldwide to administer inoculations by US pharma group Johnson & Johnson.

“By the end of June we expect to have received 4.5 million doses of Pfizer and two million doses from Johnson & Johnson,” Mkhize said.

READ ALSO: US Authorizes Pfizer-BioNTech Vaccine For 12-15-Year-Olds

South Africa earlier this year purchased AstraZeneca vaccines and then sold them to other African countries following fears that they would be less effective.

Then, after it started innoculating health workers, using the Johnson & Johnson jabs, it had to pause for two weeks mid-April to vet risks over blood clots that had been reported in the US.

After a brief lull, infections have climbed by as much as 46 percent between the last week of April and the first week of May.

South Africa has the highest number of coronavirus cases in Africa – with more than 1.6 million infections and over 55,000 deaths.

AFP

Pfizer Confirms Fake Vaccine Shots On Sale In Mexico, Poland

Empty vials of different vaccines by Moderna, Pfizer-BioNTech, and AstraZeneca against Covid-19 caused by the novel coronavirus are pictured at the vaccination center in Rosenheim, southern Germany, on April 20, 2021, amid the novel coronavirus / COVID-19 pandemic.
Christof STACHE / AFP

 

US drugmaker Pfizer on Wednesday confirmed that suspect doses of its coronavirus vaccine that were seized in Mexico and Poland were indeed fake, with doses going for as much as $1,000 a shot, according to US media.

At a clinic in Mexico some 80 people received bogus doses of the drug, which appeared to have been physically harmless, though offering no protection against the potentially deadly disease ravaging the country, a report in the Wall Street Journal said.

The vials were found in beer coolers and were initially identified by fabricated lot numbers and expiration dates, Mexican officials said.

The liquid in the confiscated vials in Poland was a cosmetic substance, thought to be anti-wrinkle cream, the company said.

“We are cognizant that in this type of environment — fueled by the ease and convenience of e-commerce and anonymity afforded by the internet — there will be an increase in the prevalence of fraud, counterfeit and other illicit activity as it relates to vaccines and treatments for Covid-19,” a Pfizer spokesperson told ABC News.

In February, health authorities in the northern Mexican state of Nuevo Leon warned about “clandestine” sales of “alleged Covid vaccines” and urged people not to take them.

In March, the World Health Organization also warned of “falsified” Pfizer vaccines found in Mexico and warned that the shots “may still be in circulation in the region.”

Pfizer tested the bogus vials and found they did not contain the two-shot vaccine it developed with BioNTech.

Lev Kubiak, Pfizer’s head of global security, said the desperate need and the shortfall in vaccines had led to the scams.

“We have a very limited supply, a supply that will increase as we ramp up and other companies enter the vaccine space. In the interim, there is a perfect opportunity for criminals,” he told the Wall Street Journal.

Mexico is also examining a shipment of 6,000 doses of what is claimed to be the Russian vaccine Sputnik that were seized on a private plane headed for Honduras last month, the newspaper said.

-AFP

Pfizer Jab 97% Effective Against Symptomatic COVID-19 Research

In this file photo taken on November 23, 2020 is pictured a bottle reading “Vaccine Covid-19” next to US pharmaceutical company Pfizer and German biotechnology company BioNTech logos on November 23, 2020.
Pharma companies Pfizer and BioNTech on December 1, 2020 filed for European approval for their coronavirus vaccine, following in the footsteps of competitor Moderna, while the OECD predicted the world economy would bounce back to pre-pandemic levels by late 2021.
JOEL SAGET / AFP

 

 

Pfizer-Biontech’s coronavirus vaccine offers more protection than earlier thought with effectiveness in preventing symptomatic disease reaching 97 percent, according to real-world evidence published Thursday by pharma companies.

Using data from January 17 to March 6 from Israel’s national vaccination campaign, Pfizer-Biontech found that prevention against asymptomatic disease also reached 94 percent.

An earlier real-world study had shown effectiveness at preventing symptomatic disease at 94 percent and asymptomatic illness at 92 percent.

BioNTech/Pfizer Say Vaccine Can Stand Warmer Temperatures

A health worker prepares a dose of the Pfizer-BioNTech vaccine against COVID-19 at Colombia University Clinic in Bogota, on February 18, 2021.
Raul ARBOLEDA / AFP

Germany’s BioNTech and its US partner Pfizer on Friday said tests have shown that their coronavirus vaccine can stand warmer temperatures than initially thought, potentially simplifying the jab’s complex cold-chain logistics.

The companies said they have asked the US Food and Drug Administration to allow for the vaccine to be stored for up to two weeks at minus 25 to minus 15 degrees Celsius (minus 13 to five degrees Fahrenheit), temperatures commonly found in pharmaceutical freezers and refrigerators.

Under the existing guidelines, the BioNTech/Pfizer jab needs to be stored at a frigid minus 80 to minus 60 C until five days before use, a delicate process that requires special ultra-cold containers for shipping and dry ice for storage.

READ ALSO: 31 Dead In DR Congo Plague Outbreak

“If approved, this new storage option would offer pharmacies and vaccination centres greater flexibility in how they manage their vaccine supply,” said Pfizer CEO Albert Bourla in a statement.

The BioNTech/Pfizer jab, based on novel mRNA technology, was the first vaccine against Covid-19 to be approved in the West late last year.

It was soon followed by US firm Moderna’s vaccine, which uses similar technology but can remain stable at minus 20 C for six months and at normal fridge temperature for up to 30 days.

Another approved shot, developed by AstraZeneca/Oxford, uses more traditional vaccine methods and can be stored and shipped at standard fridge temperatures.

BioNTech CEO Ugur Sahin said BioNTech and Pfizer were continuing to work on “new formulations that could make our vaccine even easier to transport and use”.

The firms have also started testing their Covid-19 vaccine on healthy pregnant women.

The trial involves some 4,000 pregnant women in the United States, Canada, Argentina, Brazil, Chile, Mozambique, South Africa, Britain and Spain.

Those in the US have already received their first dose, BioNTech and Pfizer said earlier this week.

Separately, a study focused on more than 9,000 medical staff at Sheba hospital near Tel Aviv showed that the first dose of the Pfizer vaccination is 85 percent effective against coronavirus infection between two and four weeks after inoculation.

AFP

BioNTech Starts Vaccine Production At New German Site

In this file photo taken on November 23, 2020 is pictured a bottle reading “Vaccine Covid-19” next to US pharmaceutical company Pfizer and German biotechnology company BioNTech logos on November 23, 2020. JOEL SAGET / AFP

 

German Covid-19 vaccine maker BioNTech said Wednesday it has started production at its new facility in Marburg, expected to significantly boost the EU’s vaccine supply.

“We have started the first step of vaccine production in our production facility in Marburg,” the company said in a statement.

The factory, whose launch was fast-tracked by German authorities, will produce mRNA, the active ingredient in BioNTech’s vaccine developed with US pharmaceutical giant Pfizer.

It will then be purified and concentrated before being transported to a “production partner” to be finished.

The European Medicines Agency (EMA) will carry out quality checks in February or March.

“The first vaccines produced at the Marburg site are expected to be delivered at the beginning of April,” BioNTech said.

READ ALSO: Prince Charles Receives First Dose Of COVID-19 Vaccine

The main European factory for producing the vaccine is Pfizer’s plant in Puurs, Belgium.

Once fully operational, the new Marburg site in Hesse state will be one of the largest mRNA production facilities in Europe, with an annual production capacity of up to 750 million vaccine doses.

BioNTech plans to produce up to 250 million doses there in the first half of 2021.

“We continue to work with Pfizer on a series of measures to meet global demand,” said the company, confirming its goal of delivering two billion doses in 2021.

BioNTech bought the Marburg plant from Swiss pharma giant Novartis last year to ramp up vaccine production, and retained the 300 employees already working there.

BioNTech had announced in mid-January that it would have to delay shipments of the jabs to the EU due to necessary modifications at the Puurs factory, sparking ire across the bloc.

But the company said in early February it would meet its contractual commitments for the first quarter and pledged to send up to 75 million extra doses to the bloc in the spring.

The EU has ordered a total of 600 million doses of BioNTech and Pfizer’s so-called Comirnaty vaccine.

Why Nigeria Was Not Included In First Shipment Of Pfizer Vaccine – WHO

This picture taken on April 24, 2020 shows a sign of the World Health Organization (WHO) in Geneva next to their headquarters, amid the COVID-19 outbreak, caused by the novel coronavirus. Fabrice COFFRINI / AFP
This picture taken on April 24, 2020 shows a sign of the World Health Organization (WHO) in Geneva next to their headquarters, amid the COVID-19 outbreak, caused by the novel coronavirus.
Fabrice COFFRINI / AFP

 

The World Health Organisation (WHO) has explained why Nigeria was not included among the countries to receive the Pfizer vaccine in Africa.

Regional Director of the WHO, Matshidiso Moeti, had said only four out of 13 interested African countries were shortlisted to receive the Pfizer vaccines through COVAX, a mechanism backed by WHO for distributing vaccines to the developing world.

Moeti who spoke at a press briefing on COVID-19 vaccine rollout in Africa on Thursday, said the countries are Cabo Verde, Rwanda, South Africa & Tunisia.

READ ALSO: African Leaders To Tackle COVID-19, Conflict At Virtual Summit

She noted that they were picked following evaluations by a multi-agency committee based on current mortality rates, new cases and trends, and the capacity to handle the ultra-cold chain needs of the vaccine.

But speaking during a briefing on Saturday in Abuja, WHO Country Representative, Dr Wondimagegnehu Alemu, said the global health body did not disqualify Nigeria for any reason.

He explained that COVAX decided to replace the initial 100,000 doses of Pfizer with 16 million doses of the Astrazeneca vaccine.

He stated that issues around population, fatalities from COVID-19 were some of the considerations the Selection Committee used in choosing which country received which vaccine.

Alemu revealed that Nigeria will receive the Pfizer vaccine as supplies increases, adding that the Astrazeneca vaccine, which is more in supply, will meet more of the needs in Nigeria.

Storage Capacities

In January, the Director-General of the Nigerian Institute of Medical Research (NIMR), Babatunde Salako, in an interview with Punch Newspaper, said the country does not have enough freezers to store the Pfizer vaccine.

The Pfizer vaccines must be stored at the ultra-cold temperature of -70°C.

But days after Salako’s interview, the Executive Director of the National Primary Health Development Agency, Dr Faisal Shuaib gave journalists a tour of the National Strategic Cold Store in Abuja.

During the tour, he said Nigeria has the capacity to store up to 400,000 doses of the Pfizer vaccine.

After Moeti’s Thursday’s disclosure that Nigeria was not among the countries to receive the Pfizer vaccine, news media reported that Nigeria had been disqualified from the process due to, among other reasons, lack of the required storage capacity.

“WHO is part of Covax facility and can never disqualify a Member State from accessing an approved vaccine for their population,” a WHO representative Kazadi Mulombo, tweeted on Saturday. “I call upon members of the press in Nigeria and globally to contribute to fighting misinformation.”

 

 

WHO, Pfizer Reach COVAX Deal For 40m COVID-19 Vaccine Doses

LAS VEGAS, NEVADA – JANUARY 12: A vial of the Pfizer-BioNTech COVID-19 vaccine is displayed at UNLV on January 12, 2021 in Las Vegas, Nevada.
Ethan Miller / GETTY IMAGES NORTH AMERICA / Getty Images via AFP

 

The WHO and pharmaceuticals giant Pfizer on Friday announced a deal for up to 40 million initial doses of the Pfizer-BioNTech Covid-19 vaccine for poorer countries, through Covax global pool.

“I’m glad to announce that Covax has signed an agreement with Pfizer-BioNTech for up to 40 million doses of its Covid-19 vaccine,” World Health Organization director-general Tedros Adhanom Ghebreyesus told a press conference in Geneva.

More to follow….

Italy Threatens Legal Action Over Pfizer Vaccine Delays

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

 

Italy has threatened to take legal action against pharma giant Pfizer over delays in deliveries of the coronavirus vaccine.

“Protecting the health of Italian citizens is not negotiable,” Domenico Arcuri, the special commissioner for the pandemic, said in a statement late Tuesday.

A meeting with ministers and regional leaders considered how to protect Italians “in all civil and criminal venues where possible”, he said.

“It was unanimously decided that these actions will be taken starting in the next few days.”

Pfizer/BioNTech’s vaccine, which was developed at record-breaking speed, was approved for use in the European Union in late December and has been quickly rolled out.

But Pfizer said last Friday it would delay shipments of vaccinations over the next three to four weeks due to works at its key processing plan in Belgium.

READ ALSO: Biden Plans Immediate Orders On Immigration, COVID-19, Environment

The following day, in a joint statement with German vaccine partner BioNTech, the US drugmaker said it had a plan to limit delays of deliveries to one week.

The delays have sparked concern across Europe, which has suffered badly from the pandemic — with Italy among the worst.

Arcuri said that 29 percent of promised doses were not delivered this week.

“The vaccination campaign cannot be slowed down, even less so for the administration of the second doses for the many Italians who have already been given the first.”

Italy has so far recorded more than 83,000 deaths from coronavirus and vaccinated more than 1.2 million people.

Phase Three Trials Begin For Novavax Vaccine In US, Mexico

KIRKLAND, WA – DECEMBER 28: Pharmacists prepare doses of the COVID-19 vaccine at the Life Care Center of Kirkland on December 28, 2020 in Kirkland, Washington. The Life Care Center of Kirkland, a nursing home, was an early epicenter for coronavirus outbreaks in the U.S. Karen Ducey/Getty Images/AFP

 

Clinical trials to determine the safety and efficacy of a Covid-19 vaccine candidate from American biotech company Novavax have begun in the United States and Mexico, the US National Institutes of Health (NIH) announced Monday.

A similar Phase 3 trial for the same vaccine, called NVX-CoV2373, is also under way in the United Kingdom, where about 15,000 volunteers have been recruited.

In the US and Mexico, the new trials will include around 30,000 volunteers over the age of 18.

Two-thirds of the participants will receive the vaccine and one-third a placebo. None of them will know, for the duration of the trial, what was in the injection they received.

“The launch of this study — the fifth investigational COVID-19 vaccine candidate to be tested in a Phase 3 trial in the United States — demonstrates our resolve to end the pandemic through development of multiple safe and effective vaccines,” said leading US immunologist Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH.

The goal is that at least 25 percent of the participants in the US and Mexico trials should be aged 65 and over, the statement said.

Emphasis will also be placed on recruiting people who are more exposed to Covid-19 — African-Americans and Hispanics in particular — or who present with underlying health conditions that put them at higher risk, such as obesity or diabetes.

READ ALSO: US Begins COVID-19 Vaccinations For Troops In South Korea

The vaccine is taken in two doses three weeks apart. It can be stored between two and eight degrees Celsius (35 and 46 degrees Fahrenheit) — much warmer temperatures than already approved vaccines from Pfizer/BioNTech and Moderna, meaning it could be more easily distributed.

The Pfizer and Moderna vaccines are based on a new technology, messenger RNA, while the Novavax vaccine is a recombinant protein vaccine.

The coronavirus has spikes (viral proteins) on its surface that come into contact with cells it infects. These proteins can be reproduced and presented to the immune system so that it can later recognize them and react if it is actually infected.

Two other vaccines that have conducted Phase 3 trials, those from Johnson & Johnson and AstraZeneca/Oxford, are expected soon to seek emergency authorization for distribution in the US, the country most affected by the pandemic in absolute numbers worldwide.

WHO In Talks With Pfizer, Moderna On COVID-19 Vaccine Access

This combination of file pictures created on August 05, 2020 shows a sign for Pfizer pharmaceutical company in Cambridge, Massachusetts, on March 18, 2017, and the Moderna headquarters in Cambridge, Massachusetts on May 18, 2020.  DOMINICK REUTER, Joseph Prezioso / AFP

 

The World Health Organization said Tuesday it is in discussions with Pfizer and Moderna about possibly including their high-tech coronavirus vaccines among early jabs for poor countries at affordable prices.

The WHO-backed Covax facility, created to ensure equitable access to Covid-19 vaccines around the world as they become available, is aiming to provide some two billion doses by the end of next year.

It has already secured hundreds of millions of doses of vaccine candidates being developed by AstraZeneca, Novavax and Sanofi-GSK.

WHO senior advisor Bruce Aylward said the organisation was looking at a range of other jabs, as well as the current frontrunners.

He said WHO was “in conversations” with Pfizer and Moderna about whether their products could be part of “early roll-out of vaccines”.

READ ALSO: Bomb Kills Deputy Governor In Afghan Capital

But, he stressed, “we also need to make sure that they are at prices that are appropriate for the populations we are trying to serve and the countries we are trying to help.”

US pharmaceutical giant Pfizer has, along with German BioNTech, created the first coronavirus jab to receive regulatory approval in a number of Western countries. Vaccination campaigns have already begun in Britain and the United States.

The Moderna vaccine is expected to quickly receive approvals as well.

– Light, but a long tunnel –
Both vaccines use cutting-edge technology and have been shown in Phase III trials to be highly effective — and they are expected to be expensive.

But Aylward hailed public comments from Pfizer chief Albert Bourla in which he talked about cutting prices for low-income countries.

“He has said we are committed to making sure that our products see global use and we recognise that requires pricing it at the right level to be able to make that work,” Aylward said.

“So there is a strong commitment from Pfizer out there to be able to do that.”

Covax wanted to have a diverse portfolio of vaccines to offer and would evaluate “any product out there with demonstrated efficacy, safety, quality”, he added.

The vaccines developed by China and Russia could also be evaluated for inclusion “if they meet the standards for efficacy and safety”, he said.

A year into the pandemic, which has claimed more than 1.6 million lives worldwide, Aylward hailed the positive vaccine news over the past month.

“There is light at the end of the tunnel,” he said. But while there was “a bright light at the end of it, getting brighter, it is a long tunnel.”

AFP

US Expert Committee Recommends Pfizer COVID-19 Vaccine Approval

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

 

 

An expert committee convened by the US Food and Drug Administration voted heavily in favor of recommending the Pfizer-BioNTech Covid-19 vaccine for emergency use approval on Thursday.

The final voting tally was 17 in favor, four against and one abstention.

The committee was tasked with answering whether, “based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh its risk for use in individuals 16 years of age and older?”

READ ALSO: Israel Gets First Delivery Of Pfizer COVID-19 Vaccine

The vote by the independent experts and researchers, including infectious disease specialists, biostatisticians and other scientists, isn’t binding but the FDA is expected to follow the recommendation within the coming days.

Britain, Canada, Bahrain and Saudi Arabia have already approved the vaccine, the first in the world to complete a large-scale, phase 3 clinical trial.

Russian and Chinese vaccines are already being administered on a large scale, but without having completed comparable clinical trials.

The full results of the trial, which included nearly 44,000 people, were published Thursday in the New England Journal of Medicine, another major milestone.

These confirmed the vaccine was 95 percent effective with no serious safety issues, an outcome that was described in an accompanying editorial as a “triumph.”

Pfizer scientist Kathrin Jansen told the panel this was a result of the innovative messenger RNA technology behind the vaccine, an approach that has never before been approved.

Britain on Wednesday reported that two health care workers developed significant allergic reactions to the vaccine as the country rolled out its massive drive Tuesday.

The FDA will therefore include a warning label on the vaccine if it’s approved, the agency’s Marion Gruber said.

AFP