Pfizer is already working on a powder form of COVID-19 vaccine

Pfizer is already working on a powder form of COVID-19 vaccine

November 12, 2020

Pfizer’s top scientist says it is already working on a powder form of COVID-19 vaccine that could solve the problem of freezing the jab – and it could be available next year

  • Pfizer’s chief scientific officer Mikael Dolsten told Business Insider Monday a second version of the vaccine is already being planned 
  • The second-generation, powder vaccine could be available next year
  • The powder vaccine would only need standard refrigeration rather than freezing
  • The pharma giant revealed promising findings from its coronavirus-vaccine study Monday, with the jab found to be 90 percent effective 
  • It is now on track to apply later this month for emergency-use approval of the vaccine from the FDA
  • Limitations of the first version include that it must be stored frozen at minus 94 degrees Fahrenheit – something some top hospitals don’t have storage for 

Pfizer’s top scientist has said it is already working on a powder form of its breakthrough COVID-19 vaccine that could solve its biggest problem around freezing the jab. 

Pfizer’s chief scientific officer Mikael Dolsten told Business Insider Monday a second version of the vaccine is already being planned and could be available next year.

The pharma giant revealed promising findings from its coronavirus-vaccine study Monday, with the jab found to be 90 percent effective in giving immunity to 94 people in a study. 

It is now on track to apply later this month for emergency-use approval of the vaccine from the FDA.

However, despite the promising findings, there are some limitations with the first version, mainly that it must be stored frozen at minus 70 degrees Celsius (minus 94 degrees Fahrenheit) – something some of the nation’s top hospitals do not currently have suitable storage for.  

Pfizer’s top scientist has said it is already working on a powder form of its breakthrough COVID-19 vaccine that could solve its biggest problem around freezing the jab

Dolsten said Pfizer has already started planning a second-generation vaccine that will solve this challenge by coming in powder form.

‘We are thinking about a few possibilities for next-generation vaccines,’ Dolsten told Business Insider. 

‘For the COVID-19 disease, I think we’ll roll out next year a vaccine in powder format.’ 

The powder vaccine would only need standard refrigeration rather than being stored frozen. 

‘We think we could already in 2021 develop a powder form that could be just for refrigeration,’ Dolsten said.  

‘That would be one simplification.’ 

He did not specify the exact temperature it would need to be stored at.  

Powder vaccines, known as lyophilized formulations, can be reconstituted before injection or sometimes administered through inhalation or intranasal vaccination.

The key benefit would be that it would not need to be stored at ultra-cold temperatures like the current version – an unusual requirement for vaccines.    

Pfizer has made preparations to transport the vaccine in the necessary conditions.

In September, the pharma giant’s executives said the jab would be shipped by air and land using dry ice and GPS temperature-monitoring devices to ensure it is kept at the right conditions. 

Pfizer’s chief scientific officer Mikael Dolsten (pictured) told Business Insider Monday a second version of the vaccine is already being planned and could be available next year

PFIZER’S VACCINE TIMELINE SO FAR

SEPTEMBER 13: Pfizer CEO Anthony Bourla says they will know if the vaccine is effective by the end of October 

OCTOBER 16: In an open letter, Bourla promises again to know if the vaccine is effective by the end of October

He said the company wouldn’t know if all three components – efficacy, safety and manufacturing – were up to par until the third week of November 

OCTOBER 30-NOVEMBER 8: No update on efficacy of the vaccine 

NOVEMBER 3: Presidential election 

NOVEMBER 7: The election is called for Joe Biden 

NOVEMBER 9: Pfizer announces results of efficacy study, says they expanded perimeters of it after consulting the FDA but doesn’t say when or why

But there are still concerns around storage once the jab reaches its destination.  

The CDC asked states last month to identify locations that could store a vaccine in temperatures of 94 degrees Fahrenheit below zero. 

But many of the US’s major hospital systems are not currently equipped with the right storage facilities. 

‘We’re a major medical center and we don’t have storage capacity like this,’ Dr. Gregory Poland, a virologist at the Minnesota-based Mayo Clinic, told Reuters. 

‘That will be true for everybody. This is a logistical obstacle.’

The challenge will be worse for developing nations where they do not have the infrastructure or funds to scale up storage facilities.       

Pfizer, which developed its vaccine with German drugmaker BioNTech, became the first to release promising preliminary findings of its jab based on early and incomplete test results.

With a possible 90 percent efficacy rate, Pfizer is on track to apply later this month for emergency-use approval from the FDA once it has the necessary safety information in hand. 

Authorities have stressed, however, that it is unlikely any vaccine will arrive much before the end of the year and the limited initial supplies will be rationed. 

The drugmaker had initially said it would know if its vaccine was effective by October but shifted that timeline last month to say it expects to seek FDA authorization in the third week of November. 

Pfizer is still on track to meet that timeline.    

The company said the results of its preliminary analysis came after a discussion with the FDA but it is not yet clear exactly what those discussions involved or when they occurred. 

Nearly 44,000 people are enrolled in Pfizer’s final testing of the vaccine. Pfizer has said that 94 people in the trial have so far tested positive for COVID-19. 

Researchers at a Pfizer facility in Belgium developing the vaccine. The pharma giant revealed promising findings from its coronavirus-vaccine study Monday, with the jab found to be 90 percent effective in giving immunity to 94 people in a study

A storage facility for the COVID-19 vaccine at a Pfizer facility in Belgium. There are some limitations with the first version, mainly that it must be stored frozen at minus 94 degrees Fahrenheit – something some of the nation’s top hospitals do not currently have storage for

Over 90 percent effectiveness implies that no more than eight of the 94 people who caught COVID-19 had been given the vaccine. 

Doing the math, that would mean almost all the infections counted so far had to have occurred in people who got the dummy shots.  

The efficacy rate is well above the 50 percent effectiveness required by the FDA for a vaccine. 

To confirm the efficacy rate, Pfizer said it will continue the trial until there are 164 COVID-19 cases among participants. 

The FDA has also said companies must track half their participants for side effects for at least two months, which Pfizer says it expects to reach later this month.

Pfizer’s initial plans called for evaluating the vaccine when just 32 infections had been counted. 

Many scientists, however, warned that was simply too small to draw conclusions about a vaccine needed by billions.

Pfizer said it reconsidered and went back to the FDA for permission to change the plan and do its first interim analysis when there were more cases. 

By the time Pfizer made the change and caught up with a backlog of virus tests, the board had 94 infections to analyze.  

The Trump administration has paid $1.95 billion for 100 million initial doses of the Pfizer vaccine. 

Pfizer says it could have up to 50 million doses available by the end of this year if approved. 

The timing of Pfizer’s announcement, which came 48 hours after Joe Biden claimed victory and less than a week after the election, quickly raised questions. 

Trump has since accused the FDA of holding up Pfizer’s vaccine until after the election and said the decision to delay it would cost lives. 

Health and human services secretary Alex Azar gave a timeline on Tuesday for when a coronavirus vaccine would be rolled out after Pfizer said a day earlier it was on track to apply later this month for emergency-use approval from the FDA

‘As I have long said, @Pfizer and the others would only announce a vaccine after the election, because they didn’t have the courage to do it before. Likewise, the @US_FDA should have announced it earlier, not for political purposes, but for saving lives!’ Trump tweeted on Monday night. 

‘The @US_FDA and the Democrats didn’t want to have me get a Vaccine WIN, prior to the election, so instead it came out five days later – As I’ve said all along!’

President-elect Joe Biden welcomed Pfizer’s news but cautioned that it could be many months before vaccinations become widespread in the US. 

He warned Americans to rely on masks and social distancing in the meantime, saying the country still faces a ‘dark winter’.  

On Tuesday, Health and human services secretary Alex Azar gave a timeline for when the vaccine would be rolled out saying the US could receive 20 million doses per month starting at the end of this month if Pfizer moves as quickly as expected to secure regulatory approval.   

‘We have anticipated that we will have enough vaccine by the end of December to have vaccinated our most vulnerable citizens in nursing homes and otherwise,’ Azar told NBC’s Today.

‘By January, enough for all health care workers and first responders and enough for all Americans by the end of March to early April to have general vaccination programs.’  

Meanwhile, Dr Anthony Fauci estimated the vaccine would be rolled out in December if the FDA approves it.  

Dr Fauci told MSNBC that Pfizer’s preliminary data was ‘impressive’ in nature and that the drugmaker’s application for emergency use authorization ‘should go through smoothly’.

‘By the time we get into December, we’ll be able to have doses available for people who are judged to be at the highest priority.’

When will the COVID-19 vaccine be rolled out and who will get it first? Everything you need to know about Pfizer’s breakthrough shot 

The global race to find a COVID-19 vaccine took a leap forward today when US drugmaker Pfizer revealed its jab is 90 percent effective. 

Pfizer, which developed a vaccine with German drugmaker BioNTech, is the first to release successful data based on an interim analysis from a large-scale coronavirus vaccine clinical trial.

The announcement from the two pharma companies fueled hope that the global pandemic could come to an end as Pfizer hailed the vaccine victory a ‘great day for science and humanity’. 

The United States has already paid $1.95 billion for 100 million initial doses of the vaccine and Pfizer says it could have up to 50 million doses available by the end of this year if approved. 

So what do you need to know about Pfizer’s vaccine?    

DOES THIS MEAN A VACCINE IS READY?

Not quite yet. 

Pfizer has released preliminary findings that suggests its vaccine is more than 90 percent effective in preventing COVID-19. 

The vaccine has been tested on nearly 44,000 people in six different countries and no safety concerns have been raised so far. 

Pfizer is now planning to apply to the Food and Drug Administration for emergency approval to use the vaccine by the end of the month. 

WHEN COULD IT BE READY FOR THE PUBLIC?

The general public will not benefit from the vaccine – if it is approved – for weeks or months to come.

Pfizer said they will try to apply for FDA approval within the next month if all goes well with the rest of their trial. 

The FDA’s scientific advisers will debate each company’s study findings in a public meeting before the agency decides.

Manufacturers already have begun stockpiling vaccine doses in anticipation of eventual approval but the first shots will be in short supply and rationed.

Pfizer expects to produce up to 50 million doses, or enough to protect 25 million people, by the end of this year. 

They expect to produce up to 1.3 billion doses of the vaccine next year.

HOW MANY DOSES HAS THE US BOUGHT?

The United States has already paid $1.95 billion for 100 million initial doses of the vaccine. 

It is enough to treat 50 million Americans. 

WHO WILL GET IT FIRST?

There is no official government announcement on who will get the COVID-19 vaccine first. 

A federal advisory that is putting together recommendations to be approved by the CDC is currently considering four groups to possibly recommend for early COVID-19 vaccination if supply is limited.

They include: Healthcare personnel, workers in essential and critical industries, people at high risk for severe COVID-19 illness due to underlying medical conditions and people 65 years and older. 

HOW DOES THE TRIAL WORK?   

Nearly 44,000 people are enrolled in Pfizer’s final testing of the vaccine. 

Neither participants, their doctors or Pfizer know who gets the real vaccine and who gets a dummy shot. 

They get a second dose about three weeks after the first and tracking begins a week after the second dose.

The tracking involves counting anyone who experiences COVID-19 symptoms and tests positive for the virus as participants go about their daily routines, especially in hotspots.  

WHAT DO THE NEW TRIAL RESULTS SHOW?

The companies said that 94 people in the trial have so far tested positive for COVID-19. 

Over 90 percent effectiveness implies that no more than eight of the 94 people who caught COVID-19 had been given the vaccine. 

Doing the math, that would mean almost all the infections counted so far had to have occurred in people who got the dummy shots.  

The efficacy rate is well above the 50 percent effectiveness required by the Food and Drug Administration for a vaccine.

To confirm the efficacy rate, Pfizer said it will continue the trial until there are 164 COVID-19 cases among participants. 

The FDA has also said companies must track half their participants for side effects for at least two months, which Pfizer says it expects to reach later this month. 

HOW TO TELL IF THE VACCINE WORKS? 

Every vaccine study is overseen by an independent board that include scientists and statisticians who have no ties to the vaccine makers.  

Before a study is complete, only the board has the power to unlock the code of who got real vaccine and who got placebo and to recommend if the shots are working well enough to stop testing early.

Those boards take sneak peeks at pre-determined times agreed to by the manufacturer and the FDA. 

The first interim analysis for Pfizer came on Sunday. 

The company reported its data monitors had counted 94 infections so far – and that among those initial cases, the vaccine appeared 90 percent effective.

To be sure of protection, the study is set to run until there are 164 infections. The more COVID-19 cases occur in the trial, the better idea scientists will have of just how protective the shots really are.

COULD THAT SNEAK PEEK HAVE COME EARLIER?  

Pfizer’s initial plans called for evaluating when just 32 infections had been counted. Many scientists, however, warned that was simply too small to draw conclusions about a vaccine needed by billions.

Pfizer said it reconsidered, going back to the FDA for permission to change the plan and do its first interim analysis when there were more cases. 

By the time Pfizer made the change and caught up with a backlog of virus tests, the board had 94 infections to analyze.

Moderna, AstraZeneca and other companies not quite as far along in their final testing all have set slightly different timepoints for when their data monitors will peek at how the shots are working.

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