Within hours, the White House changed its mind about a requirement for a possible coronavirus vaccine.
It initially sought to prohibit an FDA rule for volunteers in vaccine trials to be studied longer, before the injection receives emergency approval.
Towards the afternoon of the same day, the White House finished accepting the guidelines and the new guide on the process that pharmaceutical companies must follow was published.
The rule proposed by the Food and Drug Administration (FDA) intends that the vaccine tests comply with the
two-month follow
-
up period of the volunteers
, to thoroughly review what the side effects could be.
However, that would
not allow the
vaccine to receive the go-ahead to begin production in time for the Nov.3 election
, as the Trump Administration was seeking.
That apparently was the reason why the government initially did not want to accept the guidelines.
"Being transparent and open about the appropriate circumstances under which emergency approval for a COVID-19 vaccine will be issued is key to building public trust in the process and ensuring that vaccines are administered and available." said Dr. Peter Marks, head of the FDA's vaccination unit.
A member of the
government of Donald Trump initially opined that "there is no clinical or medical basis" to establish the requirement of follow-up to inoculated volunteers.
But hours after press reports about the rule break, the White House stopped objecting to the FDA changes.
[WHO estimates there will be no general-use COVID-19 vaccine until mid-2021]
As the new coronavirus pandemic continues to plague the world with health and economic ravages, the vaccine issue has become more of a political than a scientific issue, especially in the United States.
This, because
Trump has promised as part of his campaign that the inoculation will exist
, after months of criticism about the inaction of his Government in the face of the pandemic and its derived crises.
In the country,
at least 211,000 people
have
lost their lives due to COVID-19
and more than 7 million have been infected with the SARS-CoV2 virus, which can also leave strong consequences among those who recover.
A volunteer receives a dose as part of phase 3 development of a Johnson & Johnson vaccine.Johnson & Johnson via AP / AP
Trump himself caught the infection last week and had to be taken to a hospital for supplemental oxygen, his doctors revealed.
Despite this, the president has insisted on minimizing both the disease and protection measures against contagion, such as the use of masks.
["Someone has to do this": how a volunteer lives the tests for the first coronavirus vaccine]
The initial intervention by the White House to curb FDA guidelines on the vaccine was seen as a new act to
"undermine the credibility" of the regulatory agency
, according to former FDA commissioners who asked in a recent letter to respect scientific guidelines.
Regardless of the Trump Administration's change of mind regarding regulations, the same pharmaceutical companies have promised, like Pfizer and Johnson & Johnson, they have already signed a joint commitment not to launch any vaccine until it is safe.
The FDA has also said that no matter what the White House decides, the companies in charge of developing the vaccine know what to expect when it comes to regulations, as these are
time frames that exist for approval of many other pharmaceutical products.
"Since it is a vaccine that will be used by millions of people, the information about its safety must be impeccable," said Peter Marks, the head of the FDA's vaccination unit.
With information from AP, The Wall Street Journal and The New York Times
