- The CDC released its
first vaccine safety report (in the MMWR publication) on February 26
providing highlights received through its "V-Safe" Covid-19 vaccine
tracking system as well as through the VAERS (Vaccine Adverse Event
Reporting System). VAERS received 6,994 reports of COVID-19–associated adverse
events during the period December 14, 2020 - January 13, 2021, with more
than 90% of the non-long-term care facility reports classified as nonserious.
About 1.5 million people submitted first-dose information
and 235,000 people had submitted second-dose information to V-Safe as of
January 13, 2021. The top side effect, experienced by over 70% of respondents,
was soreness at injection site, followed by fatigue, which was experienced by
about 30% of respondents. Second dose symptoms tended to be more severe than
first dose, but did not last more than a day or two.
Comparing the side effects of the two
vaccines, more people had reactions the day after getting Moderna
vs. the the day after getting Pfizer. For both, reactions greatly
subsided within 7 days.
Data Source:
MMWR February 26, 2021
CDC vsafe data show that more people experience reactions after
the second dose, particularly on the day after receiving the second dose ("Day 1" as defined by the CDC):
- Not appearing in the first CDC safety report is a strange but not serious side effect
experienced by a small number of Moderna vaccine recipients after the first dose.
A strong round red rash suddenly appears on the arm about a week after
the vaccine is received. Called "covid vaccine arm," the rash goes away
eventually and does not usually appear again after the second dose. A physician
describes her 8th day delayed injection reaction in this Psychology Today
article.
https://www.psychologytoday.com/us/blog/heal-the-mind-heal-the-body/202101/what-s-the-new-phenomenon-called-covid-vaccine-arm
(Also read Ask a Patient
Moderna experiences, which include some covid vaccine arm reactions.)
- On April 30, the CDC released its first safety report on the Janssen vaccine, based on V-safe and VAERS data. The chart below compares Dose 2 reactions for Pfizer with the One-dose Janssen reactions using V-safe data. Note that the percentage of people experiencing various types of reactions the day after receiving the shot is similar, although injection site pain is more frequently reported the day after receiving Dose 2 of the Pfizer vaccine:
Status of recent vaccines approved internationally or in late stages of development
- February 27, the U.S. FDA gave emergency authorization for
Janssen Biotech's COVID-19 vaccine, the third to be authorized in the
U.S. The vaccine is single-dose, and works by using a "human adenoviral
vector virus", which contains a gene from SARS-CoV-2. Cells make
coronavirus spike proteins in response to that engineered virus, which
triggers an immune response. The Janssen vaccine was paused during April 12–23, 2021 due to rare CVST events, which involve blood clots in the brain’s veins (not in the arteries, as is the case for most strokes).
https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine
- While adenoviral vectors have been tested in far more
people than mRNA vaccines, the technology is used in only one commercial vaccine
today: a rabies vaccine used to immunize wild animals.
https://cen.acs.org/pharmaceuticals/vaccines/Adenoviral-vectors-new-COVID-19/98/i19
- In third-stage clinical trials for the Janssen vaccine,
the level of protection for moderate and severe COVID-19 disease varied by
geographic area: 72% protection in the United States; 66% in Latin American
countries; and 57% in South Africa, 28 days post-vaccination. The vaccine was
85% effective in preventing severe/critical cases of COVID-19 across all
geographical regions. No COVID-related deaths occured in the vaccine group. The
most commonly reported side effects were pain at the injection site, headache,
fatigue, muscle aches and nausea; most were mild to moderate in severity and
lasted 1-2 days.
https://www.nih.gov/news-events/news-releases/janssen-investigational-covid-19-vaccine-interim-analysis-phase-3-clinical-data-released
- Merck/IAVI and Merck/Themis vaccines are
under development with OWS funding.
- Sanofi and GlaxoSmithKline have a vaccine
in development with OWS funding.
- Oxford University/AstraZeneca's two-shot vaccine
has been authorized for use by a growing number of countries. The U.S.
has pre-purchased 300 million doses of the vaccine for $1.2 billion under
Operation Warp Speed. The funds also helped pay for clinical trials research and
clinical testing.While the vaccine has been shown to be effective against the
U.K. virus variant, it has much less efficacy against the South African
variant of the virus. Johnson & Johnson and
Novavax Inc. vaccines have also
been found to be less effective against the South African variant.
https://www.wsj.com/articles/astrazeneca-vaccine-doesnt-protect-against-mild-and-moderate-cases-from-south-africa-strain-11612700385
The Lancet international medical journal
published the peer-reviewed clinical trials results for Russia’s Sputnik V
vaccine, with data indicating that it is almost 92% effective in fighting
COVID-19. It has already been approved for use in many countries (check the
raps.org vaccine tracker kkfor a list).
https://www.reuters.com/article/us-health-coronavirus-russia-vaccine-idUSKBN2A21IT
RAPS vaccine tracker:
For more details on each of the vaccines on this page, along with other
vaccines approved or in development worldwide, along with dates approved, use
the The
Regulatory Affairs Professional Society (RAPS) Covid-19 Vaccine Tracker.
It includes vaccines under development around the world, along with what phase
they are in, sponsor, and source of funding. Click the green plus symbol on the
right column to view study design and more detail about each vaccine.
https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker
Also Check: Bloomberg Vaccine
Tracker Timeline
The site provides data on
vaccines given globally and in the U.S., and this page (scroll
down the page to section called "Vaccine Timeline" ) provides a
timeline of vaccines in development and distribution, including
color-coded trial status, number of people in trials,
effectiveness, and other data in easy to read chart.
https://www.bloomberg.com/graphics/covid-vaccine-tracker-global-distribution/#us
Have you gotten your Covid-19 vaccine? Because of the considerable lag time between when CDC V-Safe data is received and when it is shared with the public, please consider also sharing your experience at our web site. The ratings are available on the website within 24 hours of posting.
Click to read comments about or add your rating for the Moderna or Pfizer or Janssen vaccines.
These highlights are from recent Ask a Patient health newsletters. Subscribe on our home page.