(Noted News) — Last week Pfizer Pharmaceutical and German biotech company BioNTech announced that the research program for their upcoming COVID-19 vaccine has reported no dangerous side effects. Over 12,000 people received their second dose, and the trial, originally targeted to enlist 30,000 subjects, now aims to enroll at least 44,000 to continue testing the vaccine. The next group of people will include teenagers and people with certain medical conditions, like HIV, Hepatitis A, or Hepatitis B.
Subjects of the trial were given two doses of the vaccine, one of which was a placebo. Neither the doctors administering the vaccines nor the subjects receiving them were told which was which. Only a committee of experts observing from the outside had that information. According to Pfizer, this committee reviews all safety data on a weekly basis.
Pfizer’s chief scientific officer Mikael Dolsten confirmed that the test subjects had not shown any immediate causes for concern, saying in an investor meeting that, “so far there has been no safety signal reported.”
Representatives from both Pfizer and BioNTech said in a statement that they hope to have conclusive figures on the vaccine’s effectiveness ready by the end of October, which is presumably when it will be ready for real-world use.
“The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing. As stated previously, based on current infection rates, the companies continue to expect that a conclusive readout on efficacy is likely by the end of October,” the statement reads.
Despite no serious issues being observed at this point, researchers are still looking carefully for the beginning stages of side effects that haven’t appeared yet but could appear later. According to Pfizer’s presentation, the most common side effect so far is fatigue and mild fever, which has been experienced in about 20% of the subjects.
Pfizer’s head of vaccine research Kathrin Jansen said during the investor meeting that the subjects are directed to notify the doctors if they feel any side effects or have any health concerns.
“They would notify us if they had any safety concerns and have not done that to date.”
The vaccine contains messenger RNA, a single-stranded molecule of RNA that needs to be stored in ultra-low temperatures to survive. Pfizer executives reportedly have enough freezers to store over 100 million doses of the vaccine.
Pfizer’s president of bio-pharmaceuticals Angela Hwang said that there are three options in regards to distributing the vaccine to the public: Pfizer’s freezers, which can help providers lengthen the vaccine’s shelf-life to 6 months; thermal shipping containers packed with dry ice, which give vaccines a 15-day shelf-life; and standard refrigerators, which give vaccines a 5-day shelf-life. Providers will have a “wide range of flexibility”, according to Hwang.
Though these conditions should be workable, Pfizer is still researching ways to create an enhanced version of the vaccine that can survive in higher temperatures and has a longer shelf-life. Additionally, Pfizer is also trying to make a version that could be given in a single dose, rather than multiple ones. Such measures would aim to make distribution proceed much more efficiently.
Once the United States Food and Drug Administration approves the vaccine and the two bio companies confirm they have at least 100 million doses, the US government will reportedly pay the companies $1.95 billion.
BioNTech is receiving up to €375 million ($445.9 million) from the German Federal Ministry of Education and Research to support their efforts in developing the vaccine with Pfizer.
After news of funding from the German government, BioNTech shares (BNTX) jumped over 4% during Tuesday’s premarket. BioNTech’s jump in share price is just a continuation of the same trend; BioNTech (BNTX) has gone up nearly 100% year to date, while the S&P500 has gone up 4.7%.
Pfizer’s stock (PFE) also experienced a 6% jump in share price following the press release for the research trial and has enjoyed a 31% increase in share price since the COVID crash of March.