Pfizer to deliver 200M Covid vax shots to U.S. by May, sooner than expected

 Pfizer plans to deliver 200 million doses of its coronavirus vaccine to the U.S. by May, earlier than its initial forecast of July, according to slides published Tuesday by the drugmaker ahead of its fourth-quarter earnings call.

The company, which developed its vaccine with German drugmaker BioNTech, also said it can potentially deliver 2 billion doses globally by the end of this year now that health-care providers can extract an additional sixth dose of the vaccine from the vials. In December, the Food and Drug Administration said extra doses from vials can be used after doses were being thrown away due to labeling confusion.

Pfizer had delivered 29 million doses of its two-shot vaccine to the U.S. government as of Jan. 31, according to the company. As of Monday, 17 million of those Pfizer doses have been administered, according to the Centers for Disease Control and Prevention.

The company’s Covid-19 vaccine was the first approved for emergency use in the U.S.

Pfizer, like other coronavirus vaccine makers, has been struggling to meet the demand for shots that hopefully will help bring an end to the pandemic. It recently enlisted the help of French drugmaker Sanofi to help produce 100 million doses of its vaccine.

The update on its supply timeline comes hours after Pfizer said it expects to sell about $15 billion in coronavirus vaccine doses this year. The company also raised its full-year earnings guidance to between $3.10 and $3.20 from $3 and $ 3.10, citing “additional refinements” of its vaccine revenue forecast.

The company also said Tuesday it is “prepared to respond” if a Covid variant demonstrates evidence that it is resistant to its vaccine. In recent weeks, U.S. health officials, including Dr. Anthony Fauci, have said they are concerned that vaccines currently on the market may not be as effective in guarding against new, more contagious strains of the virus.

In the slides published, Pfizer said patients will “likely need to boost regularly to maintain immune response and to counter emerging variant strains.”

https://www.cnbc.com/2021/02/02/covid-vaccine-pfizer-plans-to-deliver-200-million-doses-to-us-by-may-sooner-than-expected.html

US FDA approval tracker: January

 The first month of 2021 saw the approval of Aurinia’s Lupkynis, one of the most valuable launches of the year, according to sellside sales forecasts. The drug, indicated for use in lupus nephritis, is Aurinia’s sole product, and with approval in the bag some believe that the prospect of a takeover has increased. Other approvals of note include an early decision on Exelixis/Ipsen’s Cabometyx in combination with Bristol Myers Squibb’s Opdivo in first-line renal cell carcinoma, which could help cement Opdivo as leader in the space by 2026. Elsewhere, Darzalex Faspro, the subcutaneous version of J&J/Genmab’s anti-CD38 MAb, gained approval in patients with newly diagnosed light-chain (AL) amyloidosis. Jefferies analysts forecast $2bn worldwide peak sales for Darzalex outside multiple myeloma, predominantly in amyloidosis. The other big regulatory news last month was a three-month delay to the FDA’s decision on Biogen’s Alzheimer’s project aducanumab, a move that many interpreted positively and caused Biogen’s shares to rise 5.5%.

Notable first-time US approval decisions in January
Project	Company	2026e sales by indication ($m)	Outcome
Lupkynis (voclosporin)	Aurinia	1,092	Approved
Cabenuva (cabotegravir + rilpivirine)	GSK/J&J	681	Approved
Tepmetko (tepotinib)	Merck KGaA	492	No decision yet
Verquvo (vericiguat)	Merck/Bayer	389	Approved
Ansofaxine hydrochloride	Luye Pharma	-	No decision yet
Vocabria (oral cabotegravir)	Glaxosmithkline	-	Approved
Sources: EvaluatePharma & company releases.

 

Supplementary and other notable approval decisions in January
Product	Company	Indication (clinical trial)	Outcome
Xalkori	Pfizer	Paediatric patients with r/r systemic Alk-positive anaplastic large cell lymphoma (study ADVL0912 and A8081013)	Approved
Nplate	Amgen	Hematopoietic syndrome of acute radiation syndrome	Approved
Enhertu	Astrazeneca	Her2 +ve gastric or gastroesophageal junction (GEJ) adenocarcinoma (Destiny-Gastric01)	Approved
Xolair	Roche	Self-administration option across all approved US indications	No decision yet
Botox	Abbvie	Detrusor (bladder muscle) overactivity, paediatric patients	No decision yet
Estelle	Mithra	Prevent pregnancy	No decision yet
Darzalex Faspro	J&J/Genmab	AL amyloidosis (Andromeda, for use in combination with bortezomib, cyclophosphamide and dexamethasone)	Approved
Opdivo plus Cabometyx	Bristol/Exelixis	1L  renal cell carcinoma (Checkmate-9ER)	Approved (~1 month early)
Sources: EvaluatePharma & company releases. https://www.evaluate.com/vantage/articles/news/snippets/us-fda-approval-tracker-january

Pfizer sees $15bn of 2021 Covid sales; could it do $30bn?

 If Pfizer has got its sums right then the sellside might seriously have to lift forecasts for its Covid-19 vaccine Comirnaty. In today’s fourth-quarter earnings report the group said it expected to book $15bn of Comirnaty sales this year, but there is apparently room to approach a number twice as high. The $15bn forecast comprises only the 780 million or so doses Pfizer has already contracted for, including 200 million to the US for $3.9bn and 300 million to the EU. But the company can “potentially deliver around two billion doses by the end of 2021”, though because the market is subject to government contracting it says it is responsible not to bake such numbers into revenue forecasts. Pfizer is splitting Comirnaty gross margins 50/50 with Biontech, but will book sales globally except in Turkey and Germany, and expects a high-20s percentage pretax profit margin on the vaccine’s sales. In December the sellside saw Moderna’s mRNA-1273 as this year’s top-selling Covid-19 vaccine, and though some analysts now expect this to sell $11bn in 2021 Pfizer has jumped ahead; the first forecasts have also emerged for Astrazeneca’s AZD1222, from Leerink, which sees $1.9bn this year and $3bn in 2022.

https://www.evaluate.com/vantage/articles/news/snippets/pfizer-sees-15bn-2021-covid-sales-could-it-do-30bn

Sputnik V fails to come in from the cold

 Interim phase III data on Sputnik V, the adenovirus-based Covid-19 vaccine developed at the Gamaleya Research Institute in Russia, were reported in the Lancet today and look solid at first glance, with a respectable efficacy rate of 91.6%.

But two deaths associated with Covid-19 among the vaccine recipients might raise concerns, though the researchers insisted that these were due to pre-existing conditions, and that the patients had been infected before they were dosed. Other intriguing aspects are the use of different adenoviral vectors for the two doses, and the storage requirements for the vaccine, which might be more onerous than expected.  

Of the participants in the Resist trial, 16 of the 14,964 vaccine recipients and 62 of those given a placebo contracted the virus. The time point at which this was assessed was unusually strict: 21 days from the first dose, ie the date of the second dose. Pivotal studies of the other prime-boost vaccines that have reported data left at least a week after the second dose for immunity to develop before assessing efficacy.

Crucially, there were no cases of moderate or severe Covid-19 in the treatment group, versus 20 with placebo. Safety was clean, with no vaccine-related serious adverse events. 

But the deaths might rankle. They were caused by cardiovascular and endocrine conditions exacerbated by Covid-19, the authors said. More importantly, the two subjects died four and five days after their first doses, allowing the researchers to conclude that they had already been infected before being included in the study, despite negative PCR tests at enrolment.

There have been no Covid-19 deaths with the other vaccines on which phase III data have been reported.

Vaccine efficacy comparison
		Covid-19			Severe Covid-19		Covid-19 death
Company	Vaccine	Vaccine	Pbo	Efficacy	Vaccine	Pbo	Vaccine	Pbo
Pfizer/Biontech	BNT162b2	8	162	95%	1	9	0	0
Moderna	mRNA-1273	11	185	94%	0	30	0	1
Gamaleya Research Institute	Sputnik V	16	62	92%	0	20*	2**	0
Novavax	NVX-CoV2373	6	56	89%	0	1	0	0
Astrazeneca	AZD1222	30	101	70%	0	2	0	1
Johnson & Johnson	Ad26.COV2.S/ JNJ-78436735	66% effective		66%	85% effective		0	Unknown
*Moderate to severe cases. **Infections judged to predate vaccination. Source: company releases, the Lancet, the NEJM.

One intriguing aspect of Sputnik V is that it uses two different adenoviruses: the first dose is based on recombinant Ad26 and the second, 21 days later, on rAd5, with both vectors carrying the gene for the full-length spike protein.

The authors wrote that using a different vector for the booster might help create a more powerful immune response than using the same vector twice – as Astrazeneca’s vaccine does, for instance – as this minimised the risk of the immune system developing resistance to the initial vector.

A question for the future is what this means for redosing after a longer interval, such as for an annual booster. If recipients become less responsive to adenoviral vectors, will new vectors have to be found for each additional shot? Or will immunity to the vectors wane along with immunity to the coronavirus, allowing their reuse? 

Moscow rules

Other questions are also pressing. The Lancet paper did not include any data on the vaccine’s effectiveness against new variants of the coronavirus, so further trials will be needed to tease this out. 

And vaccine watchers will note that Sputnik V appears more effective than the other vaccines that can be stored conveniently in fridges – those from Astrazeneca, Novavax and Johnson & Johnson. But this is not in fact the case. The vaccine used in the Resist trial was in fact a liquid formulation that requires storage at -18°C, so in storage terms the vaccine used in the trial is more similar to the mRNA vaccine from Moderna, whose efficacy was 94%. 

The freeze-dried form of Sputnik V that can be stored in a fridge is approved by Russia’s Ministry of Health, but there do not seem to be any concrete phase III data backing it.

These issues will soon come under scrutiny by EU regulators; an MAA for the vaccine is expected to be filed this month. Sputnik V is already authorised for use in 16 countries, including Hungary, Belarus and Argentina, as well as in Russia itself, which approved the vaccine last August on the strength of phase II data. 

https://www.evaluate.com/vantage/articles/news/sputnik-v-fails-come-cold

Ocugen, Bharat Biotech Agree to Commercialize COVAXIN™ in US

 

• Definitive Agreement provides details of the previously announced intent to co-develop COVAXIN™ for the US market
  

• Ocugen and Bharat Biotech to share US commercialization profits

• Ocugen to receive initial supply of COVAXIN™ doses from Bharat Biotech upon authorization from US regulatory authorities while it ramps up manufacturing in the US

• COVAXIN™ received EUA (Emergency Use Authorization) in India in January and is currently in a fully enrolled Phase 3 clinical trial involving 25,800 patients

• COVAXIN™ (whole-virion inactivated COVID-19 vaccine candidate) effectively neutralizes UK variant of SARS-Cov-2 reducing the possibility of mutant virus escape

https://finance.yahoo.com/news/ocugen-bharat-biotech-announce-execution-142700880.html

China cracks fake COVID-19 vaccine ring, confiscates 3,000 doses

 Chinese police arrested more than 80 people and confiscated over 3,000 fake doses of COVID-19 vaccine as part of a campaign to combat vaccine-related crimes, state news agency Xinhua reported.

The suspects had been carrying out the ruse since at least September last year, Xinhua said on Monday, adding that all fake doses had been tracked down.

The fake vaccines were made by injecting saline into syringes, it said. The suspects may have intended to send the vaccines abroad, the government-backed Global Times newspaper reported, citing a source close to a major Chinese vaccine producer.

The police operation was carried out by police in multiple places including Beijing, Shanghai and the eastern province of Shandong, Xinhua said.

Countries around the world from have been rolling out vaccine programmes in the hope of bringing the year-long coronavirus pandemic to an end.

https://www.reuters.com/article/us-health-coronavirus-china-vaccine/china-cracks-fake-covid-19-vaccine-ring-confiscates-3000-doses-xinhua-idUSKBN2A2031

Over half in New Delhi may have had COVID, government survey suggests

 More than half of New Delhi’s 20 million inhabitants may have been infected with the coronavirus, according to a government serological survey whose findings echoed earlier private-sector research.

India has reported 10.8 million COVID-19 infections, the most anywhere outside the United States. But Tuesday’s survey, based on some 28,000 samples, suggests the true figure among its 1.35 billion population is dramatically higher and approaching herd immunity levels.

“In the fifth sero survey done in the national capital of Delhi, (coronavirus) antibodies have been detected in 56.13% of the city’s population,” Delhi Health Minister Satyendar Jain said on Twitter after the report was published.

Separate tests done on more than 700,000 people across India by diagnostics company Thyrocare Technologies showed 55% of the population may have already been infected, its chief told Reuters last week.

The World Health Organization says at least 60% to 70% of a population needs to have immunity to break the chain of transmission, though Indian officials have said a lower level can also slow the virus’s spread.

Jain said New Delhi had largely beaten COVID, and India’s daily cases and deaths fell to eight-month lows on Tuesday.

Overall it has reported 154,486 COVID deaths, giving the country a relatively low fatality rate.

One factor in that is the country’s low average age, medical experts say. Two rich states with relatively older populations - Kerala with 3,459 cases and Maharashtra with 1,948 - now account for nearly 70% of new infections.

India has vaccinated nearly 4 million people since mid-January, when it started what the government touts as the world’s biggest immunisation campaign, which aims to inoculate over 300 million people by August.

https://www.reuters.com/article/us-health-coronavirus-india/over-half-in-new-delhi-may-have-had-covid-govt-survey-suggests-idUSKBN2A21GI