The debate over whether and how broadly to approve additional “booster” doses of COVID-19  vaccines is expected to play out this month. This much is certain: The FDA’s Vaccines and Related Biological Products Advisory Committee will discuss whether to recommend booster doses for the Pfizer/BioNTech COVID-19 vaccine (COMIRNATY®, BNT162b2) meets on September 17.

After that, it’s anyone’s guess what will happen. The FDA typically follows the recommendations of its advisory panels—as it did last December when it granted an emergency use authorization (EUA) for Pfizer and BioNTech, followed a week later by an EUA for Moderna (mRNA-1273, marketed in Europe as Spikevax®), and in February by an EUA for Johnson & Johnson (Janssen Pharmaceutical Cos)’s single-shot COVID-19 vaccine.

However, the FDA’s acting commissioner Janet Woodcock, MD, has joined Rochelle P. Walensky, MD, MPH, director of the Centers for Disease Control and Prevention, in urging President Joe Biden’s administration to postpone a plan they helped draft, and which he announced August 18—to begin distributing booster doses of COVID-19 vaccines starting the week of September 20.

According to The New York Times, which cited unnamed sources, Woodcock has since maintained privately that setting a firm date to start the booster shots was risky until regulators have thoroughly reviewed data in support of that decision.

The booster doses would add to the billions Pfizer, BioNTech, and Moderna have reaped from their COVID-19 vaccines this year, and should reap again next year: “We expect Pfizer/BioNTech and Moderna could each see annual sales of roughly $2 billion,” Morningstar analyst Damien Conover wrote August 18. Morningstar has projected strong vaccine sales for Pfizer/BioNTech ($35 billion in 2021 and $39 billion in 2022) and Moderna ($21 billion in 2021 and $22 billion in 2022), with growth expected to come from sales in developing markets and third-dose booster sales in the U.S. and other developed markets.

The Pfizer/BioNTech and Moderna vaccines accounted for 70% of the total combined $36.907 billion in sales generated during January-June 2021 by the top-selling 11 COVID-19 vaccines and drugs for which sales figures have been disclosed (or in the case of one company, suggested in an investor presentation)—and compiled by GEN in this A-List.

Each drug or vaccine is listed by its name(s), sponsor(s), first half 2021 sales as disclosed by sponsor(s), U.S. sales, second-quarter 2021 sales, and the sponsors’ 2021 sales guidance to investors, with a comparison to forecasts as of the first quarter where available.

Total COVID-19 vaccine and drug sales of the best sellers have rocketed from the $10.91 billion in sales tallied in GEN’s A-List of Q1 2021 best sellers, and especially from the $4.23 billion in GEN’s 2020 best sellers A-List.

Unlike those previous lists, this latest list of COVID-19 best-sellers could not include CoronaVac, the vaccine developed by Sinovac, since at deadline the company had not released results for either the first or second quarters of 2021. However, an investor with a 15% stake in Sinovac, Sino Biopharmaceutical, reported a six-fold year-to-year jump in net income, to RMB 8.48 billion ($1.3 billion), with Sinovac and other associated companies and joint ventures contributing RMB 6.91 billion (about $1.1 billion) of that total: “A glimpse into the windfall made during the coronavirus pandemic by the Chinese vaccine developer,” Bloomberg News reported.

Some companies with vaccines and drugs in development are already recording sizable revenue from them. Novavax, for example, said it has generated $745.246 million in the first six months of 2021 ($298.017 million during Q2), which the company said reflected development activities relating to its vaccine NVX-CoV2373 for services performed under the U.S. government and Coalition for Epidemic Preparedness Innovations agreements.

This list does not include numerous additional COVID-19 vaccines and drugs that are well into clinical development but have yet to win any approvals or emergency authorizations from regulators. More than 300 vaccines and drugs are in development for COVID-19, according to GEN’s COVID-19 DRUG & VACCINE CANDIDATE TRACKER

 
Top Public Companies
11. Sotrovimab (formerly VIR-7831, also called GSK4182136)
 
Sponsors: GlaxoSmithKline (GSK) and Vir Biotechnology
 
H1 2021 Sales (Worldwide): £16 million ($22 million)
1
 

U.S. Sales: $0 (0%)

Q2 2021 Sales: £16 million ($22 million) 1

Guidance (Change from Q1 2021): N/A

10. Regkirona® (regdanvimab; CT-P59) 
 
Sponsor: Celltrion Healthcare
 
H1 2021 Sales (Worldwide): KRW 43.7 billion ($37.6 million)
2
 
U.S. Sales: $0 (0%)
 
Q2 2021 Sales: KRW 34.5 billion ($29.7 million) 2
 
Guidance (Change from Q1 2021): N/A
9. Single-Shot COVID-19 Vaccine (formerly JNJ-78436735, Ad26.COV2.S)
 
Sponsor: Johnson & Johnson (Janssen)
 
H1 2021 Sales (Worldwide): $264 million

 
U.S. Sales: $151 million (57%)
 
Q2 2021 Sales: $164 million
 
Guidance (Change from Q1 2021): N/A
8. Olumiant (baricitinib) 3
 
Sponsor: Eli Lilly
 
H1 2021 Sales (Worldwide): $402.2 million
3
 
U.S. Sales: $42.5 million (about 11%)
 
Q2 2021 Sales: $284.7 million
 
Guidance (Change from Q1 2021): N/A
7. Bamlanivimab and etesevimab 4
 
Sponsor: Eli Lilly
 
H1 2021 Sales (Worldwide): $959.1 million

 
U.S. Sales: $734 million (76.5%)
 
Q2 2021 Sales: $148.9 million
 
Guidance (Change from Q1 2021): $1 billion to $1.1 billion, down from $1 billion to $1.5 billion 5
6. Pandemic COVID-19 Vaccine (marketed in some countries as Vaxzevria or Covishield; formerly AZD1222)
 
Sponsors: AstraZeneca and Serum Institute of India
 
H1 2021 Sales (Worldwide): $1.135 billion 6

 
U.S. Sales: $0 (0%)
 
Q2 2021 Sales: $862 million 6
 
Guidance (Change from Q1 2021): N/A 7
5. Actemra® / RoActemra® (toclizumab)
 
Sponsors: Roche and Genentech, a Member of the Roche Group
 
H1 2021 Sales (Worldwide): CHF 1.642 billion ($1.789 billion)
8
 
U.S. Sales: CHF 689 million ($751 million)
 
Q2 2021 Sales: CHF 863 million ($940 million)
 
Guidance (Change from Q1 2021): N/A
4. Veklury® (remdesivir)
 
Sponsor: Gilead Sciences
 
H1 2021 Sales (Worldwide): $2.285 billion

 
U.S. Sales: $1.236 billion (54%)
 
Q2 2021 Sales: $829 million
 
Guidance (Change from Q1 2021): Between $2.7 billion and $3.1 billion, up from between $2 billion and $3 billion
3. REGEN-COV™ / Ronapreve™ (casirivimab/imdevimab)  
 
Sponsors: Regeneron Pharmaceuticals (REGEN-COV) and Roche (Ronapreve)
 
H1 2021 Sales (Worldwide): $4.156 billion
9
 
U.S. Sales: $2.853 billion (69%) 10
 
Q2 2021 Sales: $3.528 billion 11
 
Guidance (Change from Q1 2021): After forecasting approximately $2.9 billion earlier this year, based on a U.S. government contract 10, Regeneron said it expects only $34 million in U.S. net product sales during Q3 relative to the agreement. “U.S. net product sales of REGEN-COV in the fourth quarter of 2021 will be dependent upon acceleration of COVID-19 cases and related drug utilization,” Regeneron said August 5 in announcing its Q2 results.
2. Moderna COVID-19 Vaccine (mRNA-1273; Spikevax™ in Europe)
 
Sponsor: Moderna
 
H1 2021 Sales (Worldwide): $5.93 billion
12
 
U.S. Sales: $3.451 billion (58%)
 
Q2 2021 Sales (Worldwide): $4.197 billion 13
 
Guidance (Change from Q1): ~$20 billion, up from $19.2 billion
1. COMIRNATY® (BNT162b2)  
 
Sponsors: Pfizer and BioNTech
 
H1 2021 Sales (Worldwide): $19.927 billion
14
 
U.S. Sales: $4.072 billion (20.5%) 14
 
Q2 2021 Sales (Worldwide): $14.077 billion 15
 
Guidance (Change from Q1): $52.3 billion consisting of $33.5 billion projected by Pfizer and €15.9 billion ($18.8 billion) projected by BioNTech—up from approximately $41 billion consisting of $26 billion (Pfizer) and ~€12.4 billion ($14.7 billion; BioNTech) 16

 

References

1. Vir Biotechnology also reported $5.333 million in collaboration revenue from its profit-sharing arrangement with GlaxoSmithKline (GSK) for the sale of sotrovimab under Vir’s 2020 agreement with GSK. Vir’s contractual share of 72.5% from the sales of sotrovimab is based on revenue reported to Vir by GSK, net of cost of sales and allowable expenses (including distribution, selling and marketing expenses) in the period. GSK receives the remaining 27.5% for sotrovimab. VIR oversees development of the antibodies while GSK is responsible for commercialization and books all sales. Vir also recognized $0.9 million of royalties due to Xencor from the sale of sotrovimab.

2. Celltrion Healthcare furnished sales results for Regkirona by disclosing the monoclonal antibody’s percentage of the company’s total sales for the first and second quarters of 2021. In its presentation to analysts of second quarter 2021 results, Celltrion disclosed that Regkirona accounted for 8% of the company’s sales of KRW 431.8 billion ($372.9 million), which would be approximately KRW 34.5 billion ($29.8 million); and 2% of Celltrion’s Q1 sales of KRW 457 billion ($394.6 million) in Q1 sales, which would come to about KRW 9.14 billion (about $7.9 million).

3. The FDA on November 19, 2020, issued an Emergency Use Authorization (EUA) for the distribution and emergency use of Olumiant® (baricitinib) in combination with Gilead Sciences’ Veklury® (remdesivir) in hospitalized adult and pediatric patients two years of age or older with suspected or laboratory confirmed COVID-19 who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). On July 28, the FDA expanded its EUA for Olumiant as a COVID-19 treatment by allowing the drug’s use with or without Veklury.

4. Effective Q1, Lilly began reporting sales of its COVID-19 antibodies as a single entity, “COVID-19 Antibodies,” consisting of both sales for bamlanivimab administered alone (which were furnished during the fourth quarter of 2020) as well as sales for bamlanivimab and etesevimab administered together, pursuant to FDA Emergency Use Authorizations.

5. Lilly said its reduced guidance reflected excess inventory charges “primarily due to the combination of changes to current and forecasted demand from U.S. and international governments and near-term expiry dates of COVID-19 antibodies.”

6. Sales figures for the first half of 2021 and second quarter of 2021 do not include $33 million of collaboration revenue also reported by AstraZeneca from its licensing partner for manufacturing the vaccine and supplying 1 billion doses for low- and middle-income countries, the Serum Institute of India, which markets the vaccine under the name COVISHIELD™.

7. AstraZeneca did not furnish revenue or profit guidance for its COVID-19 vaccine in its second-quarter results, as it was expected to do earlier this year: “In general, AstraZeneca continues to recognise the heightened risks and uncertainties from the effects of COVID-19, including the impact from potential new medicines for COVID-19 in clinical development,” the company said July 29 in announcing Q2 results.

8. In reporting a 16% year-over-year sales increase for Actemra® and RoActemra® (tocilizumab) during the first half of 2021, Roche stated: “Growth was driven by the fact that a number of countries included this medicine in their treatment guidelines for severe COVID-19-associated pneumonia.” One of those countries was the U.S.: The FDA on June 24 granted emergency use authorization (EUA) to Genentech for intravenous Actemra for the treatment of COVID-19 in hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

9. Total sales for the first half of 2021 consisted of $3.508 billion for REGEN-COV and CHF 595 million ($648 million) for Ronapreve.

10. Total U.S. sales for the first half of 2021 consisted entirely of sales of REGEN-COV, and included $2.6 billion in Q2 U.S. sales from the manufacture and delivery of 1.25 million doses to the U.S. government, fulfilling the company’s entire supply contract with the Biomedical Advanced Research and Development Authority (BARDA).

11. Total sales for the second quarter of 2021 consisted of $3.061 billion for REGEN-COV and CHF 429 million ($467 million) for Ronapreve.

12. Total sales for the first half of 2021 based on the sale of 302 million doses.

13. Total sales for the second quarter of 2021 based on the sale of 199 million doses.

14. Total sales for the first half of 2021 consist of $11.3 billion from Pfizer and €7.282 billion ($8.627 billion) from BioNTech. U.S. sales during H1 2021 were reported by Pfizer from “BNT162b2 alliance revenues and direct sales.”

15. Total sales for the second quarter of 2021 consist of $7.838 billion from Pfizer and €5.266 billion ($6.239 billion) from BioNTech.

16. The BioNTech portion of guidance consists of estimated COVID-19 vaccine revenues for the 2021 financial year upon delivery of supply contracts of ~2.2 billion doses signed as of July 21, 2021. The dollar value of the ~€12.4 billion projected in Q1 by BioNTech fell during Q2 from $15.1 billion to $14.7 billion due to currency fluctuations.