Pfizer, BioNTech say their COVID-19 vaccine is more than 90% effective

By Michael Erman and Julie Steenhuysen

 

FILE PHOTO: A sign is pictured outside Pfizer Headquarters in the Manhattan borough of New York City, New York, U.S., July 22, 2020. REUTERS/Carlo Allegri

 

(Reuters) - Pfizer Inc on Monday said its experimental vaccine was more than 90% effective in preventing COVID-19 based on initial data from a large study, a major victory in the fight against a pandemic that has killed over 1 million people, roiled the world's economy and upended daily life.

 

Pfizer and German partner BioNTech SE are the first drugmakers to show successful data from a large-scale clinical trial of a coronavirus vaccine. The companies said they have so far found no serious safety concerns and expect to seek U.S. emergency use authorization later this month.

 

If authorized, the number of vaccine doses will initially be limited. Many questions also remain including how long the vaccine will provide protection. However the news provides hope that other vaccines in development against the novel coronavirus may also prove effective.

 

"Today is a great day for science and humanity," Albert Bourla, Pfizer's chairman and chief executive, said in a statement. "We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen."

 

Pfizer expects to seek broad U.S. emergency use authorization of the vaccine for people aged 16 to 85. To do so, it will need to have collected two months of safety data on around half of the study's roughly 44,000 participants, expected in late November.

 

"I'm near ecstatic," Bill Gruber, one of Pfizer's top vaccine scientists, said in an interview. "This is a great day for public health and for the potential to get us all out of the circumstances we're now in."

 

Pfizer said the interim analysis was conducted after 94 participants in the trial developed COVID-19, examining how many of them received the vaccine versus a placebo.

 

The company did not break down exactly how many of those who fell ill received the vaccine. Still, over 90% effectiveness implies that no more than 8 of the 94 people who caught COVID-19 had been given the vaccine, which was administered in two shots about three weeks apart.

 

The efficacy rate is well above the 50% effectiveness required by the U.S. Food and Drug Administration for a coronavirus vaccine.

To confirm its efficacy rate, Pfizer said it will continue the trial until there are 164 COVID-19 cases among participants. Given the recent spike in U.S. infection rates, that number could be reached by early December, Gruber said.

 

The data have yet to be peer-reviewed or published in a medical journal. Pfizer said it would do so once it has results from the entire trial.

 

Pfizer and BioNTech have a $1.95 billion contract with the U.S. government to deliver 100 million vaccine doses beginning this year. They have also reached supply agreements with the European Union, the UK, Canada and Japan.

 

To save time, the companies began manufacturing the vaccine before they knew whether it would be effective. They now expect to produce up to 50 million doses or enough vaccine to protect 25 million people this year.

 

Pfizer said it expects to produce up to 1.3 billion doses of the vaccine in 2021.

 

GLOBAL RACE

 

The global race for a vaccine has seen wealthier countries forge multibillion-dollar supply deals with drugmakers like Pfizer, AstraZeneca Plc and Johnson & Johnson Inc, raising questions over when middle income and poorer nations will get access to inoculations.

 

The U.S. quest for a vaccine has been the Trump administration's central response to the pandemic. The United States has the world's highest known number of COVID-19 cases and deaths with more than 10 million infections and more than 237,000 fatalities.

 

President Donald Trump repeatedly assured the public that his administration would likely identify a successful vaccine in time for the presidential election, held last Tuesday. On Saturday, Democratic rival Joe Biden was declared the winner.

 

Vaccines are seen as essential tools to help end the health crisis that has shuttered businesses and left millions out of work. Millions of children whose schools were closed in March remain in remote learning programs.

 

Dozens of drugmakers and research groups around the globe have been racing to develop vaccines against COVID-19, which on Sunday exceeded 50 million infections since the novel coronavirus first emerged late last year in China.

 

The Pfizer and BioNTech vaccine uses messenger RNA (mRNA) technology, which relies on synthetic genes that can be generated and manufactured in weeks, and produced at scale more rapidly than conventional vaccines.

 

Moderna Inc, whose vaccine candidate employs similar technology, is expected to report results from its large-scale trial later this month. The mRNA technology is designed to trigger an immune response without using pathogens, such as actual virus particles.

 

Pfizer alone will not have the capacity to immediately provide enough vaccines for the entire United States. The Trump administration has said it will have enough supply for all of the 330 million U.S. residents who wish to be vaccinated by the middle of 2021.

 

The U.S. government has said the vaccines will be provided for free to Americans, including the insured, uninsured and those in government health programs such as Medicare.

 

-- © Copyright Reuters 2020-11-09

 

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Lets hope they tested for "side effects"

 

1 hour ago, snoop1130 said:

Pfizer said the interim analysis was conducted after 94 participants in the trial developed COVID-19, examining how many of them received the vaccine versus a placebo.

 

The company did not break down exactly how many of those who fell ill received the vaccine. Still, over 90% effectiveness implies that no more than 8 of the 94 people who caught COVID-19 had been given the vaccine, which was administered in two shots about three weeks apart.

 

 

Maybe someone can explain, but I find the above a rather strange way to test effectiveness.

 

So if they didn't give anyone the vaccine, and they all caught COVID, that means 100% effectiveness?

16 minutes ago, Susco said:

 

 

Maybe someone can explain, but I find the above a rather strange way to test effectiveness.

 

So if they didn't give anyone the vaccine, and they all caught COVID, that means 100% effectiveness?

These tests always give a certain amount of people the real vaccine and the others placebos. Of course they don't hand out 100% placebos, that would be pointless. It's not like Pfizer is new to the game and doesn't know how to conduct a study.

BBC in meltdown on this news just wait for Thailand to say your not coming in without the astro priced Thai version made by our Chinese friends + an extra suitcase for your applicable entry paperwork ????  

47 minutes ago, Susco said:

 

 

Maybe someone can explain, but I find the above a rather strange way to test effectiveness.

 

So if they didn't give anyone the vaccine, and they all caught COVID, that means 100% effectiveness?

 

No. If no one receives the vaccine then vaccine effectiveness cannot be measured.

 

Effectiveness is tested by randomly dividing the study subjects into 2 groups, one of which receives the vaccine and one of which receives a placebo.  Then compare how many in each group get COVID.

 

90% effective means that 90% fewer people in the vaccinated group got COVID than in the control (unvaccinated) group.

 

Standard scientific methodology for a clinical trial.

2 hours ago, johng said:

Lets hope they tested for "side effects"

 

Of course they did.

 

First in the Phase I trials.

 

Then in the Phase II trials.

 

And only when those 2 stages found no serious adverse effects  did they progress to large scale Phase III trails.

 

Which have also found no serious side effects. That plus effectiveness are the 2 key parameters being studied.

Sheryl explained it well and for anyone who wants to read a bit more about the phases of clinical trials, I suggest taking a look at Wikipedia, it has a really good page on this topic.

 

https://en.wikipedia.org/wiki/Phases_of_clinical_research

Good news - and we can certainly use some good news!

10 million doses available to UK before Christmas. If true, that will really be a minor miracle.  How will being vaccinated affect quarantine rules I wonder?

4 hours ago, johng said:

Lets hope they tested for "side effects"

 

Reminds me of a cartoon I saw, 3 scientists in a lab, one is looking at the computer and says "I know we have all spent our lives studying infectious disease, but this guy on Facebook makes a lot of sense". (Paraphrase, I don't remember the exact quote).

'90% effective'

For exactly whom?

Apply to serverly, moderately, lightly infected; young vs old; male vs female; medically vulnerable due to known/7nknown pre-existing medical conditions, etc.?

90% effective with one, two, multiple injections?

More disclosure is needed.

1 hour ago, Srikcir said:

'90% effective'

For exactly whom?

Apply to serverly, moderately, lightly infected; young vs old; male vs female; medically vulnerable due to known/7nknown pre-existing medical conditions, etc.?

90% effective with one, two, multiple injections?

More disclosure is needed.

Applied to healthy people,  not to infected people. 

2 injections,  3 weeks apart. 

 

About the different groups (age, sex, vulnerable) they didn't say much afaik.

 

Why don't you just read the news yourself? 

will they pay the quarantine  bill when it  fails?

Might be a bit too early to claim success?

 

https://www.nytimes.com/2020/11/09/health/covid-vaccine-pfizer.html?name=styln-coronavirus&region=TOP_BANNER&block=storyline_menu_recirc&action=click&pgtype=LegacyCollection&impression_id=42bd7510-2315-11eb-91c5-57039cf266f6&variant=1_Show

 

Independent scientists have cautioned against hyping early results before long-term safety and efficacy data has been collected. And no one knows how long the vaccine’s protection might last.

 

The data released by Pfizer Monday was delivered in a news release, not a peer-reviewed medical journal. It is not conclusive evidence that the vaccine is safe and effective, and the initial finding of more than 90 percent efficacy could change as the trial goes on.

12 hours ago, ourmanflint said:

10 million doses available to UK before Christmas. If true, that will really be a minor miracle.  How will being vaccinated affect quarantine rules I wonder?

 10 million doses is very few - only enough for 5 million people (it is a 2 dose vaccine). Which is far less than the UK population of people over 65.

 

Can safely assume only very high risk people (e.g. care home residents, the immunsupressed and perhaps people over 80) and first responders (medical staff etc) will have a chance to be vaccinated in the near future.

 

Once vaccines are more widely available I would expect Thailand to revise its regs to allow entry by people with proof of vaccination (and posisbly also proof of circulating antibodies)  but that remains to be seen.

1 hour ago, Srikcir said:

'90% effective'

For exactly whom?

Apply to serverly, moderately, lightly infected; young vs old; male vs female; medically vulnerable due to known/7nknown pre-existing medical conditions, etc.?

90% effective with one, two, multiple injections?

More disclosure is needed.

90% effective in preventing any infection

 

the study participants included all ages and both sexes and people with some pre-existing conditions but with so very few infections at all in the vaccinated group one would nto be able to stratify it.

 

In any case pre-existing conditions etc are not thought to be risk factors for becoming infected, rather they are risk factors for severity of disease once infected.

15 hours ago, eisfeld said:

These tests always give a certain amount of people the real vaccine and the others placebos. Of course they don't hand out 100% placebos, that would be pointless. It's not like Pfizer is new to the game and doesn't know how to conduct a study.

It's not like they tell the truth either. https://www.justice.gov/opa/pr/justice-department-announces-largest-health-care-fraud-settlement-its-history

 

13 hours ago, ourmanflint said:

10 million doses available to UK before Christmas. If true, that will really be a minor miracle.  How will being vaccinated affect quarantine rules I wonder?

no good  must be Thai vaccine delivered  by Thai  doctor in Thai  Hospital after you have paid Thai  money double treble think of a number in advance for the naffest one available.......youll probably  have to sing the Thai national anthem as  well

Pfizer will be studying the recipients of the vaccine for the next two years to check for the long term efficacy of it.

3 hours ago, Sheryl said:

90% effective in preventing any infection

 

the study participants included all ages and both sexes and people with some pre-existing conditions but with so very few infections at all in the vaccinated group one would nto be able to stratify it.

 

In any case pre-existing conditions etc are not thought to be risk factors for becoming infected, rather they are risk factors for severity of disease once infected.

I read an American article that claimed the 90% effectiveness but only for one month.

Great way to make money if you need the vaccine every month.

Waiting for Anutin to pipe up that they will consider allowing it to be made in Thailand ..

So about $us20 a shot + 2 shots $40...........I wonder how long before India starts to copy it, they made a fortune out of the last Pfizer invention........

As usual, the Pfizer announcement is very general without providing much useful data. We only know that, at the time of the interim report, 94 persons involved in the trial were infected with COVID-19 and that the claimed efficacy was 90% but apparently no specific data are provided for the vaccine- and placebo groups.  A further assessment will be  made when the number of infections reaches 164.

 

There is another major obstacle, that is the vaccine has to be transported and stored at -70^oC. Even in many Western countries this is a problem and will mean that many GPs will not be able to administer the vaccine.

 

 

1 hour ago, GreasyFingers said:

I read an American article that claimed the 90% effectiveness but only for one month.

Great way to make money if you need the vaccine every month.

 There is no printed article, anywhere, that discusses this yet as the results only just announced.

 

The duration of protection is still unknown but is certainly longer than 1 month; they followed people for about 6 months I think. . Only 2 doses are currently recommended.

1 hour ago, GreasyFingers said:

I read an American article that claimed the 90% effectiveness but only for one month.

Great way to make money if you need the vaccine every month.

Can you provide a source for that claim?

 

And even if it were true, it would be a fantastic step in the right direction as it reduces the problem from a huge "how can we protect us from getting infected" to "now that we know how to protect us, how do we prolong the effect?" which is a much, much easier problem to solve. Worst case you make it cost in the range of $5 with enough economy of scale.

36 minutes ago, Sheryl said:

 There is no printed article, anywhere, that discusses this yet as the results only just announced.

 

The duration of protection is still unknown but is certainly longer than 1 month; they followed people for about 6 months I think. . Only 2 doses are currently recommended.

 

 

 

Maybe he's referring to this article

 

https://www.statnews.com/2020/11/09/covid-19-vaccine-from-pfizer-and-biontech-is-strongly-effective-early-data-from-large-trial-indicate/

In keeping with guidance from the Food and Drug Administration, the companies will not file for an emergency use authorization to distribute the vaccine until they reach another milestone: when half of the patients in their study have been observed for any safety issues for at least two months following their second dose.

 

Because the vaccine has been studied for only a matter of months, it is impossible to say how long it will protect against infection with the virus

40 minutes ago, Sheryl said:

 There is no printed article, anywhere, that discusses this yet as the results only just announced.

 

The duration of protection is still unknown but is certainly longer than 1 month; they followed people for about 6 months I think. . Only 2 doses are currently recommended.

You think wrong, the phase III trial only started at the end of July. Data for longer periods only apply to small scale phase I/II trials that furthermore involved low(er) risk groups (mostly white, age 18-55). 

46 minutes ago, Susco said:

 

 

 

Maybe he's referring to this article

 

https://www.statnews.com/2020/11/09/covid-19-vaccine-from-pfizer-and-biontech-is-strongly-effective-early-data-from-large-trial-indicate/

In keeping with guidance from the Food and Drug Administration, the companies will not file for an emergency use authorization to distribute the vaccine until they reach another milestone: when half of the patients in their study have been observed for any safety issues for at least two months following their second dose.

 

Because the vaccine has been studied for only a matter of months, it is impossible to say how long it will protect against infection with the virus

Nowhere in that article (or any other) does it state that the effectiveness is for only 1 month.

 

indeed the 90% effectiveness is based on numbers who developed COVID over a period of time, not just 30 days.

This is excellent news and exactly what the world needs to start getting out of this Covid-19 ???? show. Regardless anyone's situation, this is the biggest and best news of the year! ????