COVID-19 Vaccine Roll Out Approaches As US Closes Early For Holidays

 


Matyas BORSOS / AFP / Hungarian Foreign Ministry KK

 

US giant Pfizer and its German partner BioNTech prepared Friday to file an emergency request to roll out their vaunted vaccine while New York shut its schools and California braced for nighttime curfews heading into the US holiday season.

The world is seeking salvation from scientists and pharmaceutical giants as it returns to the grimly familiar shutdowns and closures that traumatised nations and upturned the global economy at the start of the year.

India’s hospitals are once again struggling to cope and its graveyards are filling as infections crossed nine million in the Asian giant — second only to the United States.

New Delhi quadrupled fines for those without masks in a desperate effort to stave off the dual scourge of the virus and winter pollution enveloping the megacity of nearly 22 million people.

“Initially when the virus broke (out), I thought I’ll bury 100-200 people and it’ll be done. But the current situation is beyond my wildest thoughts,” New Delhi gravedigger Mohammed Shamim told AFP.

And Mexico became the fourth country Thursday to see its death toll breach 100,000.

“We’re at a point where we don’t see a clear phase of descent,” former Mexican health ministry official Malaquias Lopez told AFP. “We don’t know where it’s going.”

– Green light –

Worldwide deaths are approaching 1.4 million and total infections nearing 57 million — although the true numbers are unknown since countries have different reporting methods and many cases go undetected.

Governments are now pinning their hopes on a vaccine that can save them from business closures that force families to seek dwindling government assistance — and stay at home orders that put people’s mental health under severe strain.

The first tangible signs of relief could come Friday when Pfizer and BioNTech file an emergency use authorisation request with the US Food and Drug Administration.

“The documents will be finalised today and tomorrow and submitted to the FDA,” BioNTech co-founder Ugur Sahin told AFP on Thursday.

The scientific head of the US operation to develop a vaccine said the final green light would probably come in December.

The BioNTech/Pfizer shot and another one being developed by the US firm Moderna have taken the lead in the global chase for a vaccine.

EU Commission president Ursula von der Leyen said the European bloc could also approve both before the end of the year.

– ‘Extraordinary advances’ –

A separate candidate vaccine being developed by the University of Oxford and AstraZeneca has shown to be safe and effective in a smaller study of order adults.

The UK government is hoping that its production can be ramped up quickly if it passes its final hurdle in a phase 3 trial and is approved.

But the unprecedented speed at which the vaccines are being developed has raised some alarm.

China’s Sinopharm revealed Friday that it has already given its experimental vaccine to nearly a million people — including state employees and students heading to study abroad.

Top US infectious disease official Anthony Fauci sought to dispel concerns about the vaccines from Pfizer and Moderna during a rare briefing by the White House task force.

“It was a reflection of the extraordinary scientific advances in these types of vaccines,” Fauci said.

The World Health Organization cautioned Friday that the anti-viral drug remdesivir that was administered to US President Donald Trump when he came down with the virus in October had “no important effect” on survival chances.

– ‘Nonsensical’ –

US infections numbers have sufficiently alarmed authorities to request that people stay at home for next week’s Thanksgiving holiday — normally the time when people travel from coast to coast to be with their families.

But not everyone is happy about the new rules.

More than 13,000 people have signed an online “Keep NYC Schools Open” petition after the city closed schools for its 1.1 million students but left open its bars and gyms.’

“Indoor dining remains open. Gyms remain open. Nail salons and barbershops remain open. Only schools are threatened with closure. This is nonsensical,” the petition says.

California will also impose a 10 pm to 5 am curfew from Saturday — a measure that mirrors one that Istanbul will start imposing for its 15 million residents on weekends starting Friday night.

The disease also claimed the life of another revered figure Friday with the passing of Serbian Orthodox Patriarch Irinej.

The 90-year-old succumbed to Covid-19 only three weeks after his informal second-in-command also died of the disease.

But people in South Australia — a giant region with fewer than two million — were given an early reprieve from strict stay-at-home orders after a pizza parlour worker came clean about misleading contact tracers.

Officials said a man who claimed he was a customer of the outlet — leading authorities to believe the strain was virulent enough to be transmitted via a takeaway box — in fact worked there.

-AFP

Pfizer CEO Sold $5.6m Worth Of Stocks On Day Of Vaccine Announcement

An electronic billboard in Times Square announces "stocks soar on vaccine hopes" on November 9, 2020 in New York City. David Dee Delgado/Getty Images/AFP
An electronic billboard in Times Square announces “stocks soar on vaccine hopes” on November 9, 2020 in New York City. David Dee Delgado/Getty Images/AFP

 

Pfizer CEO Albert Bourla sold $5.6 million of his stock in the US pharmaceutical company on the same day it announced promising results for its Covid-19 vaccine candidate, filings showed Wednesday.

The company, however, has reportedly said the sale was part of a pre-arranged periodic divestment plan when the stock reaches a certain price.

According to a disclosure with US market regulator SEC, Bourla sold 132,508 shares at $41.94 each on Monday.

An executive vice president at the company, Sally Susman, also sold around $1.8 million in stock, or 43,662 shares.

Pfizer shares rose by more than seven percent after peaking at over 15 percent on Monday, when the drugmaker announced that trials so far had shown its vaccine candidate being developed with German company BioNTech was 90 percent effective.

The company had not responded to a request for a comment from AFP, but a spokesman quoted by CNN described the sales as prearranged.

Sales at that price were previously scheduled as part of their personal financial management, the company said.

Such plans are designed to shield executives from insider trading accusations.

 

 

AFP

EU Still Testing Pfizer Vaccine, Keeps 2021 Forecast

A general view of the Pfizer world headquarters in New York is seen on November 9, 2020. – Pfizer stock surged higher on November 9, 2020 prior to the opening of Wall Street trading after the company announced its vaccine is “90 percent effective” against Covid-19 infections. The news cheered markets worldwide, especially as coronavirus cases are spiking, forcing millions of people back into lockdown. (Photo by Kena Betancur / AFP)

 

The European Medicines Agency is still reviewing the safety of a Covid-19 vaccine submitted by Pfizer and BionNTech and has not received clinical trial data, EU sources said Monday.

A “rolling review” of several potential vaccines is underway and, for now, Brussels is sticking by its forecast that one may be approved and available “early next year”, one source said.

Earlier, the companies said that ongoing trials had found that their vaccine was 90 percent effective in preventing Covid-19 infections, sending hopes soaring for an end to the epidemic.

The European Medicines Agency (EMA) has begun an expedited procedure to examine potential vaccines, and did nothing to pour cold water on reports of a breakthrough.

But a spokeswoman for the Amsterdam-based agency said they had yet to receive the results of clinical trials.

“Through rolling reviews, EMA can exceptionally evaluate data as it becomes available, ahead of a formal marketing-authorisation application,” she said.

“We evaluated the first batch of data on the vaccine, which came from laboratory studies (non-clinical data).

“The agency is currently assessing a second batch of data which relate to the quality of the vaccine, including data related to its ingredients and the way it is produced.

“Any new data available for this vaccine will be reviewed in the same way. We have not received nor assessed the emerging clinical data at this point and can therefore not comment further.”

Separately, in Brussels, a European source confirmed this and added “any prediction would be risky, but we have good indications that the first vaccine may be available early next year.”

European officials, including the president of the European Commission Ursula von der Leyen have previously used this timeline when talking about a future vaccine.

And Brussels has put funding aside to reserve tens of millions of doses of future vaccines from several companies, including that from US giant Pfizer and its German partner BioNTech.

AFP

WHO Chief Hails Pfizer Covid-19 Vaccine News As ‘Encouraging’

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

 

The World Health Organization chief hailed as “encouraging” Pfizer and BioNTech’s announcement Monday that their vaccine has in trials proved 90-percent effective in preventing Covid-19 infections.

The two pharmaceutical companies said the vaccine they have jointly developed had during Phase 3 trials provided protection to nearly all patients seven days after the second of two vaccine doses.

“We welcome the encouraging vaccine news from @pfizer & @BioNTech_Group & salute all scientists & partners around the who are developing new safe, efficacious tools to beat #COVID19,” WHO director Tedros Adhanom Ghebreyesus said in a tweet.

“The world is experiencing unprecedented scientific innovation & collaboration to end the pandemic,” he said.

As of mid-October, the WHO has identified 42 “candidate vaccines” at the stage of clinical trials, up from 11 in mid-June.

Ten of them were at the most advanced phase 3 stage, in which a vaccine’s effectiveness is tested on a large scale, generally tens of thousands of people across several continents.

WHO chief scientist Soumya Swaminathan said in a tweet Monday that the news from Pfizer and BioNTech should “encourage all developers of #COVID19 vaccines to continue with clinical trials.”

“The world needs several safe, effective & affordable vaccines to end this pandemic,” she said.

AFP

Pfizer Reverses Some Drug Price Hikes After Trump Tweet

 

Photo: MARIO TAMA / GETTY IMAGES NORTH AMERICA / AFP

 

Pfizer has reversed price increases on some drugs following White House pressure and the US drugmaker on Wednesday pledged to decide soon whether to sell its consumer drugs business.

A day after President Donald Trump threatened action on drug prices, and said on Twitter drug companies should be “ashamed” for boosting costs, the pharmaceutical giant said it would reverse price increases that took effect July 1.

In a news release late Tuesday, Pfizer said drug prices would return to their levels of prior to July 1 and would stay at that price until the end of the year, or until Trump enacts a “blueprint” on drug prices.

“Pfizer shares the President’s concern for patients and commitment to providing affordable access to the medicines they need,” Pfizer chief Ian Read said.

A Pfizer spokeswoman said the price hikes that have now been reversed affected about 40 medicines and included a number of instances in which prices were dropped.

The changes were in the “low single digits” and in some cases would not have affected the prices consumers pay because of rebates, the spokeswoman added.

The Trump administration in May outlined a plan for lower drug prices but critics have said it does not go far enough.

Share prices of leading pharma companies rose the day the plan was announced, suggesting investors did not view the changes as a significant worry to industry profits.

Pfizer’s stock price dipped 0.4 percent to $37.26 in afternoon trading on Wednesday, while other leading drugmakers including Merck and Bristol-Myers Squibb were off by similar amounts.

Pfizer also announced Wednesday it would reorganize the company into three divisions instead of two: innovative medicines, established medicines for legacy and generic products, and consumer healthcare, which will include over-the-counter drugs.

Pfizer said in October it was considering a possible sale or spin-off of the consumer healthcare business but some news reports have chronicled difficulties completing a deal.

Pfizer said it was expected to make a decision on the consumer healthcare business this year, reiterating a timeframe it had previously laid out.

AFP

Canada’s Supreme Court strips Viagra patent from Pfizer

Canada’s Supreme Court struck down the patent on global pharmaceuticals giant Pfizer Inc’s Viagra erectile dysfunction drug on Thursday and opened the door to generic competition.

A box of Viagra, typically used to treat erectile dysfunction, is seen in a pharmacy in Toronto

The court backed an appeal by Israeli-based Teva Pharmaceutical Industries Ltd – the world’s largest generic drug maker – which argued Pfizer had been too vague when filing its patent, which runs out in 2014 in Canada.

In a unanimous 7-0 verdict, the court said Pfizer had not provided enough details to identify the active ingredient in Viagra.

“Pfizer gained a benefit from the (Patent) Act – exclusive monopoly rights – while withholding disclosure in spite of its disclosure obligations under the act,” Justice Louis LeBel wrote on behalf of the court.

“As a matter of policy and sound interpretation, patentees cannot be allowed to ‘game’ the system in this way … (the patent) is invalid.”

In the past, Pfizer has successfully defended patent lawsuits from Teva in the United States, Spain, Norway and New Zealand.

“Pfizer expects to face generic competition in Canada shortly. The company … is disappointed with the court’s ruling,” the firm said in a statement e-mailed to Reuters.

Company spokeswoman Christina Antoniou, citing commercial confidentiality, declined to say how much the Canadian Viagra market is worth.

Pfizer’s Canadian patent – which came into force in 1998 – was divided into seven parts and covered 260 quintillion different chemical compounds.

But only one of the compounds – sildenafil – was active and the court said the patent had not provided enough information to allow another company to produce Viagra.

“Pfizer had the information needed to disclose the useful compound and chose not to release it,” the ruling said.

“Even though Pfizer knew that the effective compound was sildenafil at the time it filed the application … it chose a method of drafting that failed clearly to set out what the invention was.”

LeBel – who said “wilful intent to mislead has not been alleged or proven in this case” – noted that Pfizer’s submission to the Supreme Court had offered no explanation for withholding the information.

Teva took the case to the Supreme Court after two lower courts in Canada ruled against it. No one at the firm was immediately available for comment.

Damien Conover, an analyst at Morningstar, said he expects the Canadian ruling to have minimal impact on Viagra sales in the United States, even though people are more likely to buy “lifestyle” drugs such as Viagra as generics than they are to buy generic life-saving drugs.

“But I think it’ll be a minor impact. I can’t say how much it will hurt (U.S.) sales, but it’ll be minimal,” Conover added.

Even Teva isn’t expected to gain much, said Kevin Kedra, an analyst at Gabelli & Co. “I don’t think this is something that will move the needle for either company,” he said.

Viagra is Pfizer’s sixth-biggest medicine, with annual sales of about $2 billion. Its sales have been crimped by competition from Eli Lilly and Co’s longer-acting Cialis.

The case is 33951, Teva Canada Ltd against Pfizer Canada Inc et al.

Nestle to buy Pfizer baby food unit for $11.85 billion

Swiss food group Nestle is to buy U.S. drugmaker Pfizer’s baby food business for $11.85 billion, beating out French rival Danone in the battle for dominance of fast-growing emerging markets.

A Nestle logo is pictured on a factory in Orbe

The world’s biggest food company had to dig deeper than expected into its ample pockets to win the high-stakes fight for Pfizer Nutrition, which makes 85 percent of its sales in emerging markets.

“The price tag is high, however Nestle is securing a high growth/margin business with high exposure in the emerging markets. China will become the number 3 market for Nestle overall,” said Vontobel analyst Jean-Philippe Bertschy.

Nestle said the deal would add to earnings per share from the first year, and would allow cost synergies of $160 million. Bertschy estimated the deal would add about 0.5 percent to earnings per share in the first year and 1.5 percent in the following years.

Nestle shares, which hit an all-time high of 57.50 francs ahead of solid first-quarter results last week, fell 2.19 percent to 55.85 francs at 1104 GMT, compared with a 0.96 percent weaker European food and beverage index. The shares were trading ex-dividend, but were down less than the 1.95 francs payout.

“Although the growth profile, attractive margins and emerging market exposure makes this a compelling asset, we believe that the multiples being some way ahead of market expectations may dampen near term enthusiasm for the deal,” said Citi analyst Robert Dickinson.

The deal price was well above the $10 billion which had been expected. Nestle said it was paying 19.8 times expected 2012 core earnings, above previous Nestle deals in the sector when it paid 15.7 times for Gerber and 17.6 times for Novartis Nutrition, according to Citi.

Danone shares rose 2.1 percent to 53.54 euros as investors expressed relief that the French group would not have to leverage up its balance sheet to pay a big price for Pfizer.

CHINESE MARKET KEY

The Pfizer unit is a high-growth business built on its top SMA Gold brand, which ranks number five globally in the infant milk formula market – the world’s fastest-growing packaged food category – after Nestle, Mead Johnson, Danone and Abbott Laboratories, with a quarter of sale in China.

Nestle said the Pfizer business should boost its margins and it forecast its sales at $2.4 billion this year, bringing revenue from the combined business to above $7 billion.

Chief Executive Paul Bulcke said it was premature to comment on regulatory issues, but analysts have speculated Nestle might have to sell 25 percent of the Pfizer unit by disposing of interests in Latin America, southeast Asia, Australia and South Africa, which could be bought by Danone or Heinz.

Chief Financial Officer Wan Ling Martello said the deal, to be paid for by a combination of cash and debt, could close at best in six months but it could take up to a year.

Kurt Schmidt, head of Nestle Nutrition and former chief executive of the U.S. baby food group Gerber that Nestle bought in a $5.5 billion deal in 2007, said the global infant nutrition market was worth $30 billion.

He said the market is growing 10 percent annually, with emerging markets accounting for 73 percent of sales and with a 13 percent growth rate due to increasing births and affluence there.

The $6 billion Chinese market is key as it is set to double to $12 billion by 2016 to feed 16 million new births a year. Mead leads the Chinese market followed by Danone. Pfizer is fifth with an 8 percent share, while Nestle has just 4 percent.

Nestle’s roots go back to the 1860s development by Henri Nestle, a pharmacist, of the first infant formula for babies whose mothers who could not breast feed.

Nestle, which expects emerging markets to account for half of total sales by 2020 from 41 percent last year, has been an active player in recent emerging markets merger activity, taking stakes in two Chinese food companies.

“The deal makes strategic sense, it really was Nestle’s deal to lose as it very much wanted to add to its Asian business and boost growth and margins,” said Kepler analyst Jon Cox, adding the price was almost as high as Danone’s 2007 buy of Numico.

Danone paid 12.3 billion euros in 2007 for Dutch food group Numico, at the time Europe’s largest baby food producer, paying a similar multiple, a price many analysts said was too high.

REUTERS