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Bob Mason
Pfizer

Pfizer Inc. Delivers Again

Following positive 3rd phase trial results last week, Pfizer Inc. and BioNTech were back in the news on Wednesday.

Off the back of impressive trial results from Moderna Inc., Pfizer Inc. filled in some missing pieces of the jigsaw.

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The American-German partnership announced an efficacy rate of 94% for the over 65s’.

This was another big success story for the pharmas, who are now likely to deliver multiple vaccines globally.

The availability of multiple-vaccines should address logistical issues, including refrigerated transportation to warmer climates.

In addition to addressing the age vulnerability issues, Pfizer Inc. also stated that there had been no safety issues in the clinical trial phases.

Side effects reportedly included fatigue and headaches among a small number of volunteers. More importantly, however, side effects amongst the aged were on the milder side.

The FDA

Following the announcement, Pfizer Inc. is now due to submit a request for an emergency approval from the FDA.

In the wake of Donald Trump’s Presidential Election loss, the good news for the FDA is that there will no White House pressure to jump the gun.

On the FDA website, the FDA makes the following statement:

“We are committed to expediting the development of COVID-19 vaccines, but not at the expense of sound science and decision making. We will not jeopardize the public’s trust in our science-based, independent review of these or any vaccines. There’s too much at state.”

The statement is apt considering the speed at which both Pfizer Inc. and Moderna Inc. have completed 3rd phase trials.

At this point, however, there have been no reports of any major safety issues to suggest that the FDA will decline either or both.

That then brings manufacturing capacity and distribution into the picture.

While both have similar efficacy rates, Moderna Inc. has the edge over Pfizer Inc. on the logistics front.

The Moderna Inc. vaccine can be distributed at significantly higher temperatures, making it more cost-effective and easier to transport.

We continue to wait on the likes of AstraZeneca who, in partnership with the University of Oxford, are likely to be next in line to deliver clinical trial results.

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The 2nd Wave

Since the weekend, new COVID-19 cases continued to surge across Europe, the US, and beyond.

In the U.S, the total number of cases has risen to 11,873,863. That has taken the total number of cases worldwide to 56,569,692.

COVID-19 related deaths have also continued to rise, with the U.S reporting 256,262 deaths. That sits at just below 20% of 1,354,890 COVID-19 related deaths worldwide.

Things have got so dire that even U.S states are reintroducing containment measures in a bid to curb the spread. This has gone against the wishes of outgoing President Trump, who has continued to press for normal life to continue.

One other curveball for the markets and for the pharmas is the fact that the number of reinfections is also rising.

Reinfections suggest some sort of mutation in the virus that could limit the effectiveness of the current vaccines in clinical trials.

When looking back at the difficulties in suppressing HIV, it was its ability to mutate that contributed to such a lengthy search for effective treatment and a way to suppress the virus.

The Race Participants

As the race continues to heat up to deliver an effective vaccine worldwide, Moderna Inc. and Pfizer Inc. are the front runners.

AstraZeneca is a close 3rd and then there are a number of pharmas likely to deliver clinical trial results later this year and in the first quarter of next year.

As at 12th November, 670 drugs and vaccines were in development, targeting the coronavirus.

The figures are made available by statista.com and Pharma Intelligence.

Looking at the top pharmas in the race in more detail:

U.S Headquartered

Johnson & Johnson: Listed on the NYSE (“JNJ”) and headquartered in New Jersey, USA.

Mateon Therapeutics: Listed on OTCMKTS (“MATN”) and headquartered in California.

Medicago: and is headquartered in Quebec, Canada.

Merck & Co.: Listed on the New York Stock Exchange (“MRK”) and headquartered in New Jersey, USA.

Moderna Inc.: Listed on the NASDAQ (“MRNA”) and headquartered in Cambridge, Massachusetts, USA.

Novavax: Listed on the NASDAQ (“NVAX”) and headquartered in Gaithersburg, Maryland, USA.

Pfizer Inc.: Listed on the New York Stock Exchange (“PFE”) and headquartered in New York City. (Pfizer Inc. has partnered with Germany’s BioNTech SE)

Sorrento Therapeutics: Listed on the NASDAQ (“SRNE”) and headquartered in California. Currently trailing many of the front runners in the race for an effective vaccine.

Talem Therapeutics: This is a wholly-owned subsidiary of ImmunoPrecise Antibodies USA. Its parent company, ImmunoPrecise Antibodies Ltd is listed on the Toronto Stock Exchange.

Tonix Pharmaceuticals: Listed on the NASDAQ (“TNXP”) and headquartered in New Jersey.

Europe Headquartered

AstraZeneca: Listed on the London Stock Exchange (“AZN”) and headquartered in Cambridge, England and Sodertalje, Sweden.

GlaxoSmithKline: Listed on the London Stock Exchange (“GSK”) and headquartered in Brentford, England.

Grifols, S.A: Listed on the Bolsa de Madrid (“GRF”) and headquartered in Barcelona, Spain.

Sanofi: Listed on the CAC40 (“SAN”) and headquartered in Paris, France.

Asia Headquartered:

GC Pharma: Listed on the Korea Stock Exchange (“006280”) and headquartered in Yongin, South Korea.

As indicated above, the U.S pharmas make up the lion’s share of companies in the race to deliver a COVID-19 vaccine.

The Road Ahead

The key considerations for the likes of the FDA and the markets remain the same for now.

In addition to efficacy rates, other vaccine attributes include:

  • Safety: Side effects are a key consideration and any safety concerns would delay approval by government agencies. At present, Pfizer Inc. and BioNTech are accumulating safety data for the FDA. These numbers may well have a greater impact on the global financial markets than the efficacy numbers released earlier this month.
  • Effectiveness: While the latest efficacy numbers were impressive, more information on effectiveness is required. In particular, effectiveness where severe cases of COVID-19 are present.
  • Consistency in manufacturing: With the global COVID-19 pandemic raging on, pharmas will need to provide evidence that the vaccine can be mass-produced. Additionally, pharmas will also need to have the right logistics plans to deliver vaccines to facilities, hospitals, clinics, and pharmacies.
  • Durability: Some vaccines work for longer than others. For an effective COVID-19 vaccine, the durability would most likely need to be similar to that of the flu shot. Anything less and the vaccine would likely be ineffective in immunization for the winter months.

With the above in mind, Pfizer Inc. looks to have ticked the safety box, for now, leaving Moderna Inc. to follow. That will then shift the focus to manufacturing and then distribution.

There is some talk of production and the availability of a vaccine by the end of the year. On these timelines, it would therefore be safe to say that an effective vaccine would be available at the end of the first quarter, at the earliest.

Looking at the U.S equity market moves on Wednesday, concerns over the timelines need to be addressed.

The Front Runners

  • Pfizer Inc. (“PFE”) and BioNTech SE: Awaiting safety and manufacturing consistency data for emergency FDA approval.
  • AstraZeneca (“AZN”) and the University of Oxford: There have been reports of AstraZeneca’s vaccine being as much as 7 times less expensive than Pfizer’s. While Pfizer and BioNTech are currently leading the race, this could give AstraZeneca the edge, particularly across the emerging markets.
  • Moderna Inc. (“MRNA”): Experts are continuing to suggest that Moderna will deliver similar results to that of Pfizer Inc. and BioNTech. Clinical trial data could be out as early as this week. Reuters reported last week that the Swiss government has started a rolling review of its vaccine. This is to ensure a quick approval can be given should it deliver positive results. Swissmedic is also reportedly viewing vaccines under development by AstraZeneca and Pfizer & BioNTech.

Trailing Big Names

  • Johnson & Johnson: Phase 3 clinical trials are continuing and are taking place in a number of geographies. Johnson & Johnson began its phase 3 clinical trials back in September. J&J had to put trials on hold following a serious medical event. Trials resumed in late October, however. Trailing Pfizer and a number of others, Johnson & Johnson reportedly received additional funding to ramp up its clinical trials. Partnered with the U.S government, the U.S government has reportedly committed an additional US$454m to support phase 3 trials.
  • Medicago: Last week, Medicago released phase 1 trial results. 100% of subjects who received the trial vaccine developed significant antibody and cellular immune responses after two doses. With no safety concerns, the pharma is due to enter phase 2/3 clinical trials before the end of this year. Reuters also reported last week, that Medicago will use a booster from GlaxoSmithKline in its bid to develop an effective vaccine.
  • Novavax: While trailing the majority of the front runners, Novavax is expected to release phase 3 clinical trials from the UK in the 1st Unlikely its peers, Novavax is looking to deliver a dual vaccine. In addition to a COVID-19 vaccine, the company is looking to also include a flu vaccine. For the Novavax dual vaccine, storage of between 35F and 46F means that transport is far simpler and cheaper. One final advantage that Novavax reportedly has over its peers is production capacity.

Sanofi / GlaxoSmithKline: The partnership received a US$2.1bn funding commitment from the Trump administration to deliver a COVID-19 vaccine. Their first results are expected in early December, with late-stage trials to begin before year-end. Along with Johnson & Johnson, Medicago, and Novavax, the vaccine currently trails Pfizer, Moderna, and AstraZeneca.

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