COVID-19 Vaccine Update – The EU’s Vaccine Woes Worsen and Is Unlikely to Improve Anytime Soon

EU Vaccine News

As the EMA readies to review the AstraZeneca vaccine on 29th January, there was some bad news for EU member states.

AstraZeneca has issued a warning to EU member states to expect limited supply of the vaccine near-term.

The EU has ordered up to 400 million doses of the AstraZeneca vaccine, with up to 100 million due within the 1st quarter.

Last week, the FT reported that AstraZeneca may only deliver less than half of the 100 million doses. That means that less than 25 million would receive full protection by the early part of the 2nd quarter.

It was also reported that there was deep satisfaction within the EU Commission even though the vaccine had yet to be approved.

With the EU having made significantly smaller Pfizer Inc. and Moderna Inc. vaccine orders, the shortfall will raise further concerns over the Eurozone economy and its recovery.

Less than 50 million doses would barely make a dent in inoculating the more than 440 million population.

The bad news followed Pfizer Inc’s cut back in supply to the EU earlier in the month.

Vaccination rates across the EU remain woefully short. The latest news will continue to leave vaccination rates on the lower side that will add further pressure on governments to contain the virus by other means.

Vaccinations Rates

According to the Bloomberg Vaccination Tracker, the EU’s vaccination rate stood at 1.79 doses per 100 people as at 22nd January.

This continued to fall well short of the UK, the U.S and leading nations in the Middle East.

As at 22nd January, Israel had the highest vaccination rate of 37.14 doses per 100 people.

The U.A.E came in a distant second, with a vaccination rate of 21.76 doses per 100.

Bahrain ranked 3rd, with a rate of 9.71 (19th January), with the UK coming in 4th with a rate of 8.76 doses per 100.

With Joe Biden’s drive to vaccinate 100 million in 100 days, the U.S vaccination rate climbed to 6.04 as at 22nd January.

Looking across the EU, France was amongst the worst performers, with a vaccination rate of just 1.49.

Germany also trailed the front runners in the EU, with a rate of 1.81 doses per 100 people.

Spain and Italy had performed somewhat better, with rates of 2.51 and 2.17 respectively.

When considering the fact that these 4 member states are the worst affected, the numbers should have been better.

A lack of supply and currently low rates are a bad combination for the EU. This raises the prospects of even more restrictions to hurt the region’s economy.

For a full breakdown of vaccination rates by country, please visit Bloomberg Vaccination Tracker page here.

The Latest COVID-19 Numbers

At the time of writing, there were a total of 98,750,103 confirmed COVID-19 cases and 2,116,438 related deaths.

By geography, the U.S had reported 25,390,042 cases and 424,177 COVID-19 related deaths.

India reported 10,640,544 cases, with Brazil reporting 8,755,133 cases.

Sitting behind Russia (3,677,3520) remained the UK (3,583,907).

France (3,011,257), Italy (2,411,854), Spain (2,603,472), and Germany (2,125,261) reported a combined 10,151,844 cases.

Looking Ahead

The reported AstraZeneca supply constraints make Johnson & Johnson’s vaccine availability all the more important.

A single dose vaccine would certainly ease the strain on the EU that will now have to maintain containment measures for longer.

The EU will be able to order up to 400 million doses of the Johnson & Johnson vaccine. This would cover close to the entire EU population should a single dose vaccine receive approval.

For the EU, however, a lack of supply by AstraZeneca and Sanofi troubles mean that the entire population would not receive a vaccine for some time.

The EU had preordered 300 million doses from Sanofi, which won’t be ready until later this year at the earliest.

As the markets respond to supply issues, we can expect focus on vaccination rates, infection rates, supply to become greater near-term.

Johnson & Johnson Vaccine News

News hit the wires this week that late clinical trial results will be available within the coming weeks.

With the U.S FDA ready to review the vaccine, single dose vaccines could be available within the U.S this quarter.

The easier to transport vaccine means that governments would be able to ramp up vaccination rates. For governments lagging behind, the biggest advantage will be the fact that it is a single dose vaccine.

Approvals would need to be given, however, for distribution of the vaccine. A slow moving EMA could see the EU fall further behind its peers.

It’s worth noting that the EU had secured enough vaccine doses to cover 183.5% of the population.

While Johnson & Johnson may be able to ease the pain, it will be some time before vaccination rates hit appropriate levels.

COVID-19 Vaccine Update – The Numbers are Impressive but the Markets Need More

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.

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.

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.

COVID-19 – Moderna Delivers Even More Impressive Results

Moderna Inc. Delivers

Following Pfizer Inc. and BioNTech’s announcement, however, the markets were awaiting Moderna Inc. trial results.

The markets didn’t have to wait long. With pressure building on pharmas to deliver an effective vaccine, Moderna Inc. delivered its phase 3 trial results today.

According to the phase 3 trial results, Moderna Inc.’s mRNA-1273 vaccine was 94.5% effective in preventing COVID-19.

Not only were the numbers more impressive than that of Pfizer Inc. and BioNTech, the trial results included severe disease cases.

Efficacy rates of in excess of 90% are impressive. Both Pfizer Inc. /BioNTech and Moderna Inc. have delivered hope of an end to the pandemic.

Logistics and cost issues remain, however. Both Moderna and Pfizer Inc. will need to deliver vaccines in refrigerated containers. This raises the cost and availability of the vaccine in warmer climates. The good news for Moderna Inc., however, is that Moderna Inc.’s temperature requirements are more favorable than that of Pfizer Inc.

While positive for Moderna Inc., it also means that the likes of AstraZeneca and Novavax remain viable global alternatives should clinical trials impress.

Near-term, both Pfizer and Moderna will need to deliver safety, durability, and manufacturing sustainability data.

Favorable figures will give the two a continued edge over the rest of the front runners and those playing catch up.

The 2nd Wave

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

The impact of the negative numbers on the markets was muted, however, with Moderna Inc.’s results delivering riskier assets with yet another boost.

Looking at the latest COVID-19 numbers, the U.S has seen the total number of cases rise to 11,367,214. From the weekend, the total number of COVID-19 cases has risen by more than 500,000 to 54,896,579.

With India reporting 8,845,617 total COVID-19 cases, France has edged ever closer to the 2 million mark.

Geographically, the 2nd wave of the pandemic has been so significant that a global inoculation remains key to ending the risk of an extended economic meltdown.

The harsh reality remains that borders will remain closed until there is confidence in a global end to the pandemic.

The Race Participants

Pharmaceutical companies in the race to deliver an effective COVID-19 vaccine are vast in number. Some have progressed more than others, however, and are therefore of greater interest to governments and the global financial markets.

The companies are shown in the chart below:

statistic_id1119090_top-companies-by-covid-19-treatment-vaccines-in-development-2020

While the companies listed above were trialing 60 different drugs and vaccines. There are many more in trial phases, however. 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 10 companies listed above and a few more 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

As pharmas roll out phase 3 clinical trial results, there are other factors that remain key considerations.

In addition to efficacy rates, other considerations 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, safety will need to be proven for emergency approval. Once approvals are given, the focus will then shift to manufacturing capacity and logistics.

Governments including those of EU member states, the U.S, and beyond continue to place orders.

Any hint of a distributable vaccine by year-end should provide riskier assets with further support.

As we covered over the weekend, the front runners remain unchanged and are summarized below.

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. Trials had to be put 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 due out 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.

What’s to come?

With Moderna Inc. now having delivered, the focus will shift to Sanofi and AstraZeneca. The two are likely to deliver the next set of results.

Phase 3 trial results will not be enough, however. The pharmas will need to support global inoculation. That means that safety, manufacturing capabilities, and durability will also become a factor in the race to delivering a global vaccination.

It remains a tall order as key economies enter the winter months. While the phase 3 clinical trial results are positive to date, a global inoculation remains a difficult task. This continues to leave the race to deliver a global vaccine wide open.

COVID-19 – Updates on Vaccine Trials are coming. Is Pfizer Still out Ahead?

The 2nd Wave

COVID-19 continued to spread over the weekend, with the total number of COVID-19 cases standing at 54,328,752 at the time of writing.

While there are reportedly 37,871,087 who have recovered, there have been 1,318,278 related deaths.

The U.S and India continue to have the largest number of cases, with the U.S reporting 11,226,038 cases. Additionally, the U.S also has the largest number of COVID-19 related deaths, currently at 251,256.

Things also continue to be bleak across Europe, with France nearing 2 million cases after having overtaken both Italy and Spain.

While the total number of cases in Italy and Spain sit at 1,492,608 and 1,144,552 respectively, the UK has also seen a jump in new cases. At the time of writing, the total number of new cases stands at 1,344,356.

With the winter months rapidly approaching, the race towards an effective COVID-19 vaccine has intensified.

More cases and more COVID-19 related deaths are anticipated, in spite of governments introducing containment measures.

For the U.S, the headline figure will likely get far worse before any effective vaccine is widely available. The outgoing administration continues to leave the economy open, in spite of new daily cases sitting at record highs.

As a result, market sentiment and updates from the pharmas on when a vaccine is likely to be available remain key to risk sentiment.

The Race Participants

Pharmaceutical companies in the race to deliver an effective COVID-19 vaccine are vast in number. Some have progressed more than others, however, and are therefore of greater interest to governments and the global financial markets.

The companies are shown in the chart below:

statistic_id1119090_top-companies-by-covid-19-treatment-vaccines-in-development-2020

While the companies listed above were trialing 60 different drugs and vaccines. There are many more in trial phases, however. As at 12th November, 670 drugs and vaccines were reportedly in development, targeting the coronavirus.

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

Looking at the top 10 companies listed above and a few more 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 Clinical Trials

Last week, Pfizer and BioNTech SE spurred a global equity market rally, with their impressive phase 3 clinical trial results.

As the week wore on, however, greater awareness led to some apprehension over what lies ahead.

While Pfizer announced an efficacy rate of more than 90%, there are a number of other important considerations. As importantly, there is also some way to go before an effective vaccine is available worldwide.

Other Vaccine Considerations

In addition to efficacy rates, other considerations 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 care facilities, hospitals, clinics, and pharmacies,
  • Durability: Some vaccines are effective 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.

So, as clinical trial data begins to hit the news wires, the markets will also need to begin focusing on the other considerations. For emergency approvals to be given by the likes of the FDA, safety requirements must be met as a minimum.

While Pfizer Inc. and BioNTech SE are currently out in front, a number of other pharmas are likely to release results imminently.

The World Health Organization has listed more than 200 vaccines in the works, with 48 currently in clinical evaluation. The WHO’s overview of COVID-19 candidate vaccines is available to download here.

The Front Runners

  • Pfizer Inc. (“PFE”) and BioNTech SE: Awaiting safety, duration, 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 that 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. Trials had to be put 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 quarter. 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, more favorable storage requirements mean 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. The first results are due out 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.

What Lies Ahead

We can expect plenty of updates in the coming weeks and we will see plenty of movement in the respective stocks.

Pharmas trailing, in the event of further positive news, will likely come under further pressure.

For Pfizer, safety results, manufacturing, and durability results will be in focus near-term. For Moderna and AstraZeneca phase 3 clinical trial results will be in focus. With AstraZeneca commencing vaccine production ahead of approvals, favorable results could give them an edge.

Trailing pharma/government partnerships may also announce further investment commitments to bridge the gap.

Sanofi to Acquire Principia Biopharma for $3.7 billion; Analysts Optimistic on Outlook

Sanofi SA, a French multinational pharmaceutical company headquartered in Paris, said it would acquire a U.S.-based biopharmaceutical company Principia Biopharma for approximately $3.7 billion, sending its shares up about 1%.

Under the terms of the merger agreement, Sanofi will commence a cash tender offer to acquire all outstanding shares of Principia common stock for $100 per share in cash for a total enterprise value of approximately $3.36 billion, the company said.

Sanofi expects to complete the acquisition in the fourth quarter of 2020.

At the time of writing, Sanofi shares traded nearly 1% higher at EUR 86.03 on Monday. The stock is down about 5% so far this year.

On the other hand, Principia Biopharma stock jumped over 11% to $101 in pre-market trading on Monday. The stock is up more than 65% so far this year.

Executives’ comments

“This acquisition advances our ongoing R&D transformation to accelerate the development of the most promising medicines that will address significant patient needs,” Sanofi Chief Executive Paul Hudson said in the statement.

“The merger will provide global resources to get these novel therapies to patients faster,” said Martin Babler, president and chief executive at Principia Biopharma.

Principia Biopharma stock forecast

Six analysts forecast the average price in 12 months at $112.83 with a high forecast of $130.00 and a low forecast of $100.00. The average price target represents a 24.34% increase from the last price of $90.74. All six analysts rated ‘Buy’, according to Tipranks.

SVB Leerink raised price target to $112 from $80 and Guggenheim gave a “Buy” rating and target price of $100.

Sanofi stock forecast

Morgan Stanley target price is EUR 107 with a high of EUR 130 under a bull scenario and EUR 75 under the worst-case scenario. Other equity analysts also recently updated their stock outlook. Independent Research lowered the target price to EUR 105 from EUR 108.00; rated Buy.

Kepler Capital Markets set a EUR 99 price target on Sanofi. The brokerage currently has a buy rating on the stock. UBS Group set a EUR 101 price target and gave the company a buy rating. Goldman Sachs Group set a EUR 105 target price and gave the company a buy rating. At last, Credit Suisse Group set a EUR 105 price objective and gave the company a buy rating.

Analysts’ views

“Principia acquisition makes strategic sense – we estimate implied peak SAR’168 sales of 3-4.5 billion euros,” said Mark D Purcell, equity analyst at Morgan Stanley.

“We value Sanofi using a DCF analysis, which incorporates government bond yield curves and the Sanofi CDS in generating a blended WACC of 6.8%. We assume a progressive return of the ROCE towards the European peer-group average over a 15-year fade period and we use a +1% terminal growth rate,” Morgan Stanley’s Purcell added.

“We reiterate our Buy rating and are increasing our price target to $108 from $77 to what we believe starts to more accurately reflect our initial conservative projections,” said Joseph Pantginis, equity analyst at H.C. Wainwright & Co.

Upside and Downside risks to Sanofi

Upside: Dupixent outperforms expectations, faster R&D turnaround, value-creative M&A, regulatory progress on the Rx-to-OTC switches of Cialis and Tamiflu, COVID-19 pandemic makes flu vaccination a global priority, highlighted by Morgan Stanley.

Downside: Dupixent growth slows as competitors take market share, the pipeline does not deliver (6 focus assets), management fails to turn around R&D and execute on cost-saving, value destructive M&A.