COVID Update: Vaccine Booster Shots, Alternate Treatments Wrap Up
Pfizer (PFE Get Pfizer Inc. Report and its German partner BioNTech (BNTX Get BioNTech SE Sponsored ADR Report filed for Emergency Use Approval from U.S. regulators for their COVID-19 vaccine for young children Thursday, adding to the growing list of drugmakers fighting SARS-CoV-2.
However, with global COVID cases passing 236 million, and deaths linked to the disease topping 5 million, health authorities are concerned that President Joe Biden's aim of providing booster shots for American citizens will limit vaccine supplies to poor and developing countries heading into the winter months.
In addition to vaccines and booster shots, the effort to prevent infections may be improving as well, with alternate treatments like Merck & Co.'s (MRK Get Merck & Co., Inc. (MRK) Report COIVD pill currently under review alongside other antibody treatments.
With that in mind, TheStreet has compiled a list of vaccine approvals, booster shot applications and treatment developments that have either received or are pending FDA approval as of October 7.
1. Johnson & Johnson: Vaccine & Booster Shot
The agency has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee to review the request on October 15. A similar meeting of the Advisory Committee on Immunization Practices for the Centers for Disease Control and Prevention is likely to follow shortly after.
Johnson & Johnson won Emergency Use Authorization (EUA) approval for its single-shot COVID vaccine, which it developed with its Janssen Pharmaceutical, on February 27. The company plans to file for a Biologics License Application (BLA) with the FDA later this year.
2. Moderna: Vaccine & Booster Shot
The FDA is leaning toward authorizing half-dose booster shots of the Moderna (MRNA Get Moderna, Inc. Report COVID vaccine, Bloomberg News reported last week on Tuesday, citing people familiar with the matter. An FDA panel will hold a meeting on October 14 to discuss the third dose.
Moderna submitted an application seeking authorization for a booster shot of its two-dose vaccine on September 2, just days after its messenger-RNA based vaccine was approved for a booster shot in immunocompromised patients.
Moderna posted stronger-than-expected second quarter earnings of $6.46 per share in August, up from a 31 cents per share loss for the same period last year, as vaccine sales surged to $4.2 billion.
Moderna was granted and FDA EUA for the COVID vaccine on December 17.
3. Pfizer/BioNTech: Vaccine & Booster Shot
Pfizer and BioNtech have asked the FDA to approve emergency use of their COVID-19 vaccine for children aged five to 11, Pfizer said in a tweet on Thursday.
The FDA authorized the limited use of a booster dose of the Pfizer and BioNTech vaccine for older adults and some high-risk Americans last month, after the pair submitted early stage clinical trial data that showed promising antibody triggers with few side-effects.
Pfizer submitted data to the FDA from a late-stage trial of its coronavirus vaccine on children between the ages of 5 and 11 on September 28 that it said showed a "favorable safety profile and elicited robust neutralizing antibody responses using a two-dose regimen" at lower levels than used in adults.
Pfizer has said sales of its vaccine, first labelled as BNT162b2, could reach $33.5 billion this year as it boosted it 2021 earnings forecast to between $3.95 and $4.05 per share.
The Pfizer/BioNtech vaccine, now known as 'comirnaty', was first granted an FDA EUA on December 11.
In August, the FDA gave the vaccine full clearance for people 16 and older.
4. Ocugen: Vaccine
Ocugen (OCGN Get Ocugen Inc Report, a developer of gene therapy treatments said Tuesday that it reached a joint development-and-supply agreement with India's Bharat Biotech involving its COVID vaccine candidate.
The whole virion inactivated vaccine, known as Covaxin, was granted emergency use approval in India on January 3 following results that showed an efficacy rating of 78%.
Ocugen is reportedly preparing for a full BLA with the FDA, as opposed to an EUA process, although its efficacy rate remains far lower than that of either Pfizer or Moderna's.
5. AstraZeneca: Antibody Treatment
If authorized, the treatment -- known as AZD7442 -- would become the first such preventive treatment to be available in the United States, the company said.
AstraZeneca's two-shot COVID vaccine which is in more than 100 countries, although the Anglo-Swiss drugmaker has not filed for EUA approval in the Untied States.
6. Merck & Co.: COVID Pill
Last week, Merck said it would seek EUA approval from the FDA for a CVOID pill it said will cut the risk of hospitalization and death in high-risk patients by as much as 50%.
The drug, known as molnupiravir would offer an at-home treatment option for COVID patients and be the first oral treatment approved to fight the respiratory-focused disease.
SVB Leerink analyst Daina Graybosch said "molnupiravir could "not only unlock over $10 billion in near-term orders ... but could also "represent the best option for bringing the pandemic under control worldwide."
Merck scrapped the development of its two experimental COVID vaccine candidates last January, after early clinical-trial data showed the shots generated disappointing immune responses against the virus.
7. Regeneron: Antibody Treatment
Regeneron's REGN-COV2 cocktail, famously used in the treatment of President Donald Trump, is a combination of two monoclonal antibodies, is designed to prevent coronavirus infections.
Last month, TheStreet.com founder Jim Cramer said Regeneron is the stock to look at if the government urges American’s to get a booster shot for the COVID-19 vaccine.
He noted that states hit hard by COVID-19, such as Florida, Louisiana and Texas, have ordered “a ton” of monoclonal antibodies. “So that’s going to boost Regeneron’s quarter,” Cramer said.
8. Gilead Sciences: Antibody Treatment
In May, the FDA granted EUA approval for the drug allowing hospitals and doctors to use it as part of their in-patient treatment.
The intravenous drug has helped shorten the recovery time of some hospitalized COVID patients and was also used to treat President Donald Trump, who tested positive for the virus in October of last year.