This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

In a widely expected move, the Food and Drug Administration has expanded its emergency use authorization for Pfizer (NYSE: PFE) and BioNTech's (NASDAQ: BNTX) COVID-19 vaccine to include people as young as 12 years old.

The widened authorization for BNT162b2 was based on the ability of the vaccine to induce the production of COVID-19 antibodies; the levels of antibodies it generated in clinical trial participants ages 12 through 15 were at least as good as the antibody levels in participants in the 16-to-25 age range.

Those antibodies appear to protect patients from being infected by the coronavirus.

Measured starting one week after they received their second doses of BNT162b2, none of the 1,005 adolescents who were inoculated developed COVID-19. Among the 978 trial participants who received placebo shots, there were 16 cases of COVID-19. That equates to a finding of 100% protection, although the numbers in the study were relatively small.

The side effect profile for the adolescents was similar to that seen in those 16 and older. In both groups, people had more side effects after the second dose than the first dose.

Pfizer and BioNTech beat Moderna (NASDAQ: MRNA) to the finish line in terms of gaining FDA authorization for their vaccine to be administered to adolescents. However, BNT162b2's period of exclusivity in that demographic, which presumably will only last for a couple of months, isn't likely to be much of a financial advantage. Large sales contracts with the U.S. government are already in place for both mRNA vaccines, so opening the use of BNT162b2 to a wider age group won't increase its sales. Until another vaccine is authorized for adolescents, some of Pfizer's doses will be used for adolescents, and any supply tightening that might cause for the adult demographic will be filled by Moderna's vaccine or Johnson & Johnson's.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

The post Pfizer and BioNTech's COVID-19 vaccine authorized by the FDA for adolescents appeared first on The Motley Fool Australia.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

More reading

• 3 ASX dividend shares raising dividends like clockwork
• 3 ASX 200 blue chip shares to buy with $20,000
• I'd buy this ASX dividend stock in any market
• $10,000 invested in Zip shares one month ago is now worth…
• How to build a $500,000 ASX share portfolio step by step

Brian Orelli, PhD has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. recommends Johnson & Johnson and Moderna Inc. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Bruce Jackson.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

Berkshire Hathaway (NYSE: BRK.A) (NYSE: BRK.B) filed its Form 13F with the Securities and Exchange Commission on Monday, which gave investors a look at what the Oracle of Omaha and his team of investors bought in the third quarter.

Among the list were four pharmaceutical companies: AbbVie (NYSE: ABBV), Merck (NYSE: MRK), Bristol Myers Squibb (NYSE: BMY), and Pfizer (NYSE: PFE). The first three were similarly sized purchases of around $1.8 billion. The Pfizer purchase was substantially smaller, with a market value around $136 million.

Within the industry, there doesn't seem to be a theme among the four drugmakers.

Merck and Bristol Myers are heavily into oncology. Bristol Myers expanded its cancer treatments last year with the acquisition of Celgene. Merck is hanging its hat on Keytruda with plans to spin out its women's health and cardiovascular drugs, as well as some other brands into Organon & Co. next year.

AbbVie is looking to diversify away from its reliance on its megablockbuster Humira, which treats a variety of inflammatory disorders. The pharmaceutical company made a big move into dermatology with the acquisition of Allergan, the maker of Botox, which closed earlier this year.

Pfizer is currently most famous for its coronavirus vaccine, but the pharma giant is quite diversified. Like Merck, Pfizer is looking to get more focused by merging its Upjohn generic-drug business with Mylan in a new company called Viatris that's scheduled to start trading on Tuesday. Investors will have to wait for the next Form 13F to see what Buffett does with the shares of Viatris that all Pfizer shareholders received.

The pharmaceutical companies do have one thing in common: They're all trading off their all-time highs and have been for all of 2020, suggesting Buffet might be bargain shopping.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

The post Warren Buffett bought 4 pharma giants in Q3 appeared first on The Motley Fool Australia.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

More reading

• How to build massive wealth with ASX shares
• Market meltdown? Follow Warren Buffett's 5-step investing strategy

Brian Orelli, PhD has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. owns shares of and recommends Berkshire Hathaway (B shares) and recommends the following options: long January 2021 $200 calls on Berkshire Hathaway (B shares), short January 2021 $200 puts on Berkshire Hathaway (B shares), and short December 2020 $210 calls on Berkshire Hathaway (B shares). The Motley Fool Australia has recommended Berkshire Hathaway (B shares). We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) started the phase 3 clinical trial for their coronavirus vaccine BNT162b2 around the same time as Moderna Inc (NASDAQ: MRNA) started its phase 3 study for mRNA-1273.

But all signs point to Pfizer and BioNTech generating faster efficacy data than Moderna. Here's why:

1. Faster coronavirus vaccine booster shot

Pfizer and BioNTech give the booster shot for their vaccine 21 days after the initial dose, while Moderna's protocol calls for doctors to wait 28 days before giving the second dose. Since the efficacy measurements don't start until after the second dose is administered, the difference produces a week advantage for Pfizer and BioNTech.

2. COVID-19 efficacy readout is quicker

The efficacy in both clinical trials is based on the rate of COVID-19 among participants who receive the vaccine compared to the participants who receive placebo. But Pfizer and BioNTech decided to measure the rate of infection after seven days, while Moderna doesn't start measuring efficacy until 14 days after the second dose.

The difference creates an additional seven-day advantage for Pfizer and BioNTech compared to Moderna. Of course it's only an advantage if patients are truly protected during that seven-day period. Presumably the decisions of seven days for Pfizer and BioNTech vs. 14 days for Moderna were based on when the companies saw the formation of antibodies in earlier studies, but Moderna's conservative approach could end up benefiting the company with a slower-but-more-accurate efficacy readout.

3. Quicker enrollment

Since the efficacy measurement is events driven, early enrollment of participants in the study should help the companies generate efficacy data quicker.

Pfizer and BioNTech appear to have the edge here too, with 28,146 participants having received two doses of their vaccine as of Oct. 5,  compared to 19,369 participants in Moderna's clinical trial as of the update a few days earlier on Oct. 2.

Potential bonus: Interim readouts

If BNT162b2 works really well, Pfizer and BioNTech could have a time advantage over Moderna based on how the companies have set up their clinical trials.

Both studies incorporate multiple interim evaluations of efficacy to determine whether the studies should be stopped early if it's clear the vaccine is working. Pfizer and BioNTech have interim looks after 32, 62, 92, and 120 participants have developed COVID-19. Moderna's study only incorporated interim looks after 53 and 106 cases of COVID-19.

While the protocols offer an opportunity for Pfizer and BioNTech to call their clinical trial a success after 32 events, well before Moderna can even take a look at its data at 53 events, investors should keep in mind that the extra peeks at the data come at a statistical cost.

As a result, if both studies go to the end of their analysis, Pfizer and BioNTech need the vaccine efficacy to be 52.3% at the final readout with at least 111 of the 164 positive patients in the group who received placebo. Because Moderna has fewer interim looks, the biotech company only needs a vaccine efficacy of 49.5%, or 101 of the 151 positive patients falling in the placebo group, to call the clinical trial a success.

Is "October" vs "Thanksgiving" all that important?

Pfizer and BioNTech have told investors that data could come as early as October, while Moderna's management has said data should be available around Thanksgiving. That's only a few weeks' difference, with the obvious caveats that neither group can really know the timeline given the unknown infection rate.

The first group with data will have an advantage if it can gain the Food and Drug Administration's attention after requesting an emergency use authorization (EUA). But in a pandemic, the FDA's workload isn't necessarily a first-in-first-out situation. Better efficacy by the second vaccine maker could even the playing field, or perhaps even give it an advantage in the timing of authorizations.

And investors should keep in mind that demand is likely to outstrip manufacturing capacity. While the timing of an EUA is important, if the authorizations come in similar time frames, the group with the ability to manufacture the most vaccine is likely to capture the largest market share.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

The post 3 reasons Pfizer and BioNTech will have coronavirus vaccine data before Moderna appeared first on The Motley Fool Australia.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

More reading

• 3 ASX dividend shares raising dividends like clockwork
• 3 ASX 200 blue chip shares to buy with $20,000
• I'd buy this ASX dividend stock in any market
• $10,000 invested in Zip shares one month ago is now worth…
• How to build a $500,000 ASX share portfolio step by step

Brian Orelli, PhD and the Motley Fool have no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

Johnson & Johnson (NYSE: JNJ) has moved into phase 3 development of its coronavirus vaccine candidate, which goes by the code name JNJ-78436735. The study, called Ensemble, will enroll up to 60,000 volunteers across three continents.

The company trails Moderna Inc (NASDAQ: MRNA), AstraZeneca plc (NYSE: AZN), and the duo of Pfizer inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX), which are all in the process of finishing up enrollment in phase 3 clinical trials for their own COVID-19 vaccine candidates. It may also take Johnson & Johnson longer to reach full enrollment in its study given its larger size. Moderna plans to enroll 30,000 people in its trial, while AstraZeneca is shooting for 50,000 across multiple phase 3 studies, and Pfizer and BioNtech recently announced that they had increased their enrollment target from 30,000 to 44,000.

While Johnson & Johnson may lagging behind the pace-setters in this race, its one-dose format would give it a huge advantage over the leading vaccine candidates, all of which require a booster shot three to four weeks after the initial vaccination. The company is planning on running a separate phase 3 study to see whether two doses of JNJ-78436735 provide stronger protection than one, but the immune responses in participants receiving just one dose in the phase 1/2a study looked solid enough to continue testing under that dosing regimen.

The one-shot format will also mean that Johnson & Johnson will be able to get initial efficacy data more quickly -- measured from the start of enrollment to readout -- because it won't have to wait until trial participants get booster shots before starting to count cases of COVID-19 among them.

Johnson & Johnson says it hopes to have enough data from the study to allow it to gain FDA emergency use authorization for the vaccine in early 2021. Investors should keep in mind that the healthcare conglomerate has committed to selling JNJ-78436735 on a not-for-profit basis, so regardless of how it might ultimately fare in the COVID-19 vaccine market, it won't affect the company's earnings.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

The post Johnson & Johnson (NYSE:JNJ) starts late-stage coronavirus vaccine clinical trial appeared first on The Motley Fool Australia.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

More reading

• New to investing? 3 ASX ETFs to set and forget for 10 years

Brian Orelli, PhD has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. recommends Johnson & Johnson. The Motley Fool Australia has no position in any of the stocks mentioned. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

After reviewing the adverse event that caused AstraZeneca plc (NYSE: AZN) to pause the clinical trials of its coronavirus vaccine, AZD1222, an independent review determined there's nothing to worry about.

Or at the very least, there's not enough evidence to determine whether there is something to worry about.

"After independent review, these illnesses were either considered unlikely to be associated with the vaccine or there was insufficient evidence to say for certain that the illnesses were or were not related to the vaccine," the clinical trial organizers for the phase 2/3 U.K. clinical trial wrote in the participant-information sheet, which was updated on Friday.

The volunteers developed "unexplained neurological symptoms including changed sensation or limb weakness," which is a little more descriptive than simply calling it an "unexplained illness," as AstraZeneca did when it acknowledged that the clinical trials had been paused last week.

The U.K. clinical trials testing AZD1222 have restarted, but the 30,000-participant U.S.-based clinical trial remains on hold while the drugmaker waits for the monitoring committee for that study to sign off on restarting the study.

During its investor-day presentation yesterday, Pfizer Inc. (NYSE: PFE) said that there hadn't been any pauses in the clinical trials of its coronavirus vaccine, BNT162b2, which it is developing with BioNTech SE (NASDAQ: BNTX). Pfizer continuously monitors the safety data, and an independent data-monitoring committee (DMC) reviews the data weekly. Pfizer isn't privy to whether adverse events are in patients given the active vaccine or placebo, but the DMC gets unblinded data, so they can eliminate adverse events in patients receiving placebo as obviously not caused by the active vaccine.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

The post Coronavirus vaccine trial adverse event was probably unrelated to treatment appeared first on The Motley Fool Australia.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

More reading

• 3 ASX dividend shares raising dividends like clockwork
• 3 ASX 200 blue chip shares to buy with $20,000
• I'd buy this ASX dividend stock in any market
• $10,000 invested in Zip shares one month ago is now worth…
• How to build a $500,000 ASX share portfolio step by step

Brian Orelli, PhD and The Motley Fool Australia has no position in any of the stocks mentioned. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

Less than a week after investors learned that AstraZeneca (NYSE: AZN) had paused the clinical trials testing its coronavirus vaccine, AZD1222, the UK's Medicines Health Regulatory Authority (MHRA) determined it was safe for the company to restart the studies.

The pause was triggered by an adverse event – clinical-trial speak for a potential side effect – in one participant in the clinical trial. Pauses, which are fairly common in large clinical trials, give companies time to determine if the adverse event was caused by the vaccine. An independent committee for the UK studies reviewed the data and recommended to the MHRA that the clinical trials were safe to resume.

About 18,000 people have been vaccinated with AZD1222, which is also being tested in phase 3 clinical trials in Brazil, South Africa, and the US AstraZeneca didn't say when the clinical trials outside of the UK would be restarted.

AstraZeneca also didn't disclose publicly what the illness was, but multiple sources have reported that the company's CEO Pascal Soriot said on a call organised by the investment bank J.P. Morgan that the patient experienced serious neurological symptoms that were consistent with transverse myelitis, a spinal inflammatory disorder.

Shares of AstraZeneca were up just 0.7% in late-afternoon trading on the news, but the drugmaker had already regained most of the decline its shares suffered after the clinical-trial pause was disclosed.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

The post AstraZeneca resumes UK clinical trials of its coronavirus vaccine after a safety pause appeared first on The Motley Fool Australia.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

More reading

• 3 ASX dividend shares raising dividends like clockwork
• 3 ASX 200 blue chip shares to buy with $20,000
• I'd buy this ASX dividend stock in any market
• $10,000 invested in Zip shares one month ago is now worth…
• How to build a $500,000 ASX share portfolio step by step

Brian Orelli, PhD and The Motley Fool have no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

According to an article in Stat, AstraZeneca (NYSE: AZN) has paused the U.S. clinical trial of its coronavirus vaccine, AZD1222, after a serious possible adverse event arose in a patient enrolled in a clinical trial testing AZD122 in the U.K.

At this point, the nature of the adverse event is not known, and it isn't clear whether it was caused by AZD122. The company is "working to expedite the review of the single event to minimize any potential impact on the trial timeline," according to Stat. The participant is expected to recover. 

In addition to the 30,000-participant U.S. study announced last week, AstraZeneca is also running clinical trials in the U.K., Brazil, and South Africa. The company plans to start studies in Japan and Russia as well. All told, the studies will enroll up to 50,000 participants globally.

It isn't publicly known exactly how many patients have received AZD1222, but investors can get some clues from Moderna (NASDAQ: MRNA), which had enrolled 21,411 participants in its late-stage coronavirus vaccine clinical trial as of Friday. Meanwhile, vaccine collaborators Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) had enrolled 25,189 participants as of an update on Monday.

With that many people enrolled in coronavirus clinical trials, it's highly likely that one of the participants would develop a serious illness unrelated to the vaccination. Of course, proving that it's unrelated could be challenging and might only be possible by testing AZD122 on more participants. If the adverse event only occurs in one out of 50,000 participants, it's either unrelated or a side effect with such a low incidence level that it's a tolerable issue.

Shares of AstraZeneca were down 6.5% at 6:40 p.m. EDT in after-hours trading.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

The post AstraZeneca coronavirus vaccine clinical trial paused appeared first on The Motley Fool Australia.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

More reading

• 3 ASX dividend shares raising dividends like clockwork
• 3 ASX 200 blue chip shares to buy with $20,000
• I'd buy this ASX dividend stock in any market
• $10,000 invested in Zip shares one month ago is now worth…
• How to build a $500,000 ASX share portfolio step by step

Brian Orelli, PhD has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

Moderna (NASDAQ: MRNA), one of the leaders in the race to develop a coronavirus vaccine, was able to take the initial coronavirus sequence and get a vaccine candidate, mRNA-1273, ready for a phase 1 clinical trial in just 42 days.

The biotech's use of Amazon Web Services (AWS), the cloud-based computing service run by Amazon (NASDAQ: AMZN), enabled this quick development. Moderna runs its Drug Design Studio on AWS, which allows it to design its mRNA drug candidates quickly.

The potential drugs are further analyzed using machine learning to optimize the sequence for manufacturing. And with Moderna's manufacturing systems running on AWS, converting the vaccine sequences to physical mRNA vaccine candidates ready for preclinical testing was a straightforward process.

Of course, Amazon can't take all the credit. While AWS undoubtedly helped speed up the process, Moderna's mRNA platform played a big role in the biotech developing a candidate so quickly. Protein-based vaccines are lagging behind mRNA vaccine-makers, such as Moderna and BioNTech (NASDAQ: BNTX), simply because protein-based drugs take longer to design and optimize – especially at the manufacturing step – as the proteins have more complex structures than mRNAs.

Rather than dealing with the challenging protein step, Moderna and BioNTech let the patients' cells translate the mRNA sequence into a protein that can elicit an immune reaction just like injecting the protein directly into the patient.

If mRNA-1273 passes its ongoing phase 3 clinical trial, AWS could come into play again. As Moderna ramps up manufacturing capabilities, AWS will allow for a quick technology transfer of its manufacturing model into its partners' facilities.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

The post How Moderna went from coronavirus sequence to a phase-1-ready vaccine candidate in 42 Days appeared first on The Motley Fool Australia.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

More reading

• How to invest in the AI Build-Out: Expert
• Why ASX investors dumped IVV ETF last month
• These 3 ASX ETFs can help protect your portfolio in 2026
• 2 ASX shares booming on electrification and mining. Is there more upside ahead?

John Mackey, CEO of Whole Foods Market, an Amazon subsidiary, is a member of The Motley Fool’s board of directors. Brian Orelli, PhD has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. owns shares of and recommends Amazon and recommends the following options: long January 2022 $1920 calls on Amazon and short January 2022 $1940 calls on Amazon. The Motley Fool Australia has recommended Amazon. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.