Tag Archives: COVID-19 vaccine

Pfizer CEO made $5.6 million stock sale on same day as COVID-19 vaccine update: filing

(Reuters) – Pfizer Inc Chief Executive Officer Albert Bourla sold $5.56 million worth of company shares on Monday, the day the drugmaker said its COVID-19 vaccine was 90% effective based on interim trial results, a regulatory filing showed.

Bourla authorized the sale of the shares on Aug. 19, provided the stock was at least at a certain price, as part of a predetermined plan, the company said.

Bourla sold 132,508 shares at $41.94 per share, according to a Securities and Exchange Commission filing late Tuesday.

“The sale of these shares is part of Dr. Bourla’s personal financial planning and a pre-established (10b5-1) plan, which allows, under SEC rules, major shareholders and insiders of exchange-listed corporations to trade a predetermined number of shares at a predetermined time,” Pfizer said.

Pfizer said on Monday its experimental COVID-19 vaccine was more than 90% effective based on initial trial results, sending its shares higher along with the broader markets.

The company’s shares rose as much as 15% to trade at session high of $41.99 on Monday, before closing up 7.7%. They were trading at 38.75 on Wednesday.

Pfizer and German partner BioNTech SE have said no serious safety concerns were found so far and expect to seek U.S. emergency use authorization this month, raising the chance of a regulatory decision as soon as December.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Shinjini Ganguli and Shounak Dasgupta)

We may soon have a COVID-19 vaccine. But will enough people take it?

By John Miller and Kate Kelland

ZURICH/LONDON (Reuters) – With COVID-19 vaccine trial results looking positive, governments and pharmaceutical firms face their next daunting challenge: convincing the world to get inoculated.

Public resistance to vaccines has been much discussed this year, but the issue became very real on Monday when Pfizer and BioNTech announced their candidate was more than 90% effective in large trials – hoisting an actual shot onto the horizon.

Numerous opinion polls carried out before and during the pandemic showed confidence is volatile, and that political polarization and online misinformation threatens uptake. Many people have concerns about the accelerated speed of COVID-19 vaccine development.

The World Health Organization estimates about 70% of people must be inoculated to break transmission of the virus. Since it is unlikely a vaccine, once approved, will be immediately available for the masses, experts said getting medical workers on board will be critical.

“We should have really targeted discussions and engagement with healthcare providers,” Heidi Larson, director of the global Vaccine Confidence Project, told Reuters.

“Not only are they going to be the first ones expected to get a vaccine – if not required to – they’re also going to be the ones on the frontlines facing the onslaught of questions from the public.”

FIRST IN LINE?

While about 200 COVID-19 vaccine candidates are in development globally, with dozens in human clinical trials, no shot has actually crossed the finish line and been approved, though the one from Pfizer-BioNTech appears to be on track.

The high rate of efficacy in the Pfizer-BioNTech interim results could help boost confidence, Cornell University government Professors Douglas Kriner and Sarah Kreps said.

Their recently published research showed that if an initial COVID-19 vaccine was about as effective as a flu shot, uptake by the American public may fall far short of the 70% level needed to achieve “herd immunity.”

“However, if the vaccine was 90% effective it would significantly increase Americans’ willingness to vaccinate by more than 10%, critical to ensuring enough public acceptance to help the U.S. eventually get closer to herd immunity,” said Kreps.

Experts are also cautioning any conversation over a vaccine’s risks and rewards must be frank. A return to normal life will still take time, with no one shot likely to be a silver bullet. And many questions are likely to remain, including how long a vaccine will provide protection.

The Reagan-Udall Foundation for the FDA, a non-profit that supports the U.S. Food and Drug Administration, has been holding focus groups to gauge the public mood and is now crafting campaign messages to help tackle concerns.

Its chief executive, Susan Winckler, said more than a dozen focus groups of 150 people in total held since August – some in person, some by video – had unearthed numerous concerns.

“We heard distrust of both government and the healthcare system,” Winckler said. “Many didn’t want to be first in line for the shot.”

It’s a global phenomenon; a survey from early November, carried out by the World Economic Forum and covering 18,526 people in 15 countries, showed 73% of people willing to get a COVID-19 vaccine, a four-point fall since August.

EARLY BATTLE

Regulators and the drug industry have taken pains to reassure the public they won’t cut corners on safety, with a top U.S. drug agency official saying he would quit if an unproven vaccine were rubber stamped.

The International Federation of Pharmaceutical Manufacturers & Associations, a drug industry group, also plans a campaign by 2021, while the U.S. Council for International Business, with 300 multinational corporations as members, is also getting behind a campaign pushing for workforce take-up of eventual COVID-19 vaccines.

Some studies show government and employer recommendations will help convince people to get vaccinated.

Scott Ratzan, co-leader with Larson of ‘CONVINCE’, an initiative supporting communication and engagement for vaccine uptake globally, stressed the importance of medical workers getting inoculated, saying others would then be more likely to follow suit.

“If we don’t have the medical folks signed on … we’ll lose the early battle,” he added. “The only way to get back to normal is if we can get enough workers or employees covered.”

(Reporting by John Miller in Zurich and Kate Kelland in London; Additional reporting by Martinne Geller in London, Doug Busvine in Frankfurt and Julie Steenhuysen in Chicago; Editing by Josephine Mason and Pravin Char)

Britain prepares for COVID-19 vaccine as Oxford forecasts result this year

By Alistair Smout and Guy Faulconbridge

LONDON (Reuters) – Late-stage trial results of a potential COVID-19 vaccine being developed by the University of Oxford and AstraZeneca could be presented this year as the British government prepares for a possible vaccination rollout in late December or early 2021.

A vaccine is seen as a game-changer in the battle against the coronavirus, which has killed more than 1.2 million people worldwide, shuttered swathes of the global economy and turned normal life upside down for billions of people.

There are more than 200 candidates under development and the vaccine being developed by Oxford and licensed to British drugmaker AstraZeneca is seen as a front-runner.

“I’m optimistic that we could reach that point before the end of this year,” Oxford Vaccine Trial Chief Investigator Andrew Pollard said of the chances of presenting trial results.

Pollard told British lawmakers that establishing whether or not the vaccine worked would likely come this year, after which the data would have to be carefully reviewed by regulators and then a political decision made on who should receive it.

“Our bit – we are getting closer to but we are not there yet,” Pollard, director of the Oxford Vaccine Group, said.

Asked if he expected the vaccine would start to be deployed before Christmas, he said: “There is a small chance of that being possible but I just don’t know.”

The National Health Service (NHS) in England is preparing to start distributing possible COVID-19 vaccines before Christmas in case one is ready by the end of the year.

The Oxford/AstraZeneca vaccine is expected to be one of the first from big pharma to be submitted for regulatory approval, along with Pfizer and BioNTech’s candidate.

“If I put on my rose-tinted specs, I would hope that we will see positive interim data from both Oxford and from Pfizer/BioNTech in early December and if we get that then I think we have got the possibility of deploying by the year end,” Kate Bingham, the chair of the UK Vaccine Taskforce, told lawmakers.

Prime Minister Boris Johnson said there was the prospect of a vaccine in the first quarter of 2021. AstraZeneca is presenting its third quarter financial results on Thursday.

‘GAME CHANGER’

Work on the Oxford viral vector vaccine, called AZD1222 or ChAdOx1 nCoV-19, began in January. It is made from a weakened version of a common cold virus that causes infections in chimpanzees.

The chimpanzee cold virus has been genetically changed to include the genetic sequence of the so-called spike protein which the coronavirus uses to gain entry to human cells. The hope is that the human body will then attack the novel coronavirus if it sees it again.

If Oxford’s vaccine works, it could eventually allow the world to return to some measure of normality.

Asked what success looked like, Pollard said: “Good is having vaccines that have significant efficacy – so whether, I mean, that is 50, 60, 70, 80 percent, whatever the figure is – is an enormous achievement.

“It’s a complete game changer and a success if we meet those efficacy end points,” he said, adding it would relieve pressure on the health system.

But Pollard and Bingham agreed that the world would not return to normal immediately. Asked about the chances of a vaccine that would wipe out the coronavirus next year, Bingham said the prospects were “very slim.”

“(But the chances) to get a vaccine that has an effect of both reducing illness, and reducing mortality (are) very high,” Bingham said, adding she was more than 50% confident there would be such a vaccine by early summer.

(Reporting by Alistair Smout and Guy Faulconbridge; Editing by Nick Macfie and Alexander Smith)

COVID-19 vaccine may be ready by year-end: WHO’s Tedros

By Stephanie Nebehay

GENEVA (Reuters) – A vaccine against COVID-19 may be ready by year-end, the head of the World Health Organization (WHO) said on Tuesday, without elaborating.

WHO Director-General Tedros Adhanom Ghebreyesus called for solidarity and political commitment by all leaders to ensure equal distribution of vaccines when they become available.

“We will need vaccines and there is hope that by the end of this year we may have a vaccine. There is hope,” Tedros said in closing remarks to the WHO’s Executive Board meeting that examined the global response to the pandemic.

The EU health regulator has launched a real-time review of a COVID-19 vaccine developed by U.S. drugmaker Pfizer and Germany’s BioNTech, it said on Tuesday, following a similar announcement for rival AstraZeneca’s jab last week. The announcement by the European Medicines Agency (EMA) could speed up the process of approving a successful vaccine in the bloc.

Nine experimental vaccines are in the pipeline of the WHO-led COVAX global vaccine facility that aims to distribute 2 billion doses by the end of 2021.

So far some 168 countries have joined the COVAX facility, but neither China, the United States nor Russia are among them. The Trump administration has said it is relying instead on bilateral deals to secure supplies from vaccine makers.

“Especially for the vaccines and other products which are in the pipeline, the most important tool is political commitment from our leaders especially in the equitable distribution of the vaccines,” Tedros said.

“We need each other, we need solidarity and we need to use all the energy we have to fight the virus,” he said.

(Reporting by Stephanie Nebehay in Geneva; Editing by Michael Shields and Alexandra Hudson)